5,095 Quality Assurance Director jobs in the United States

QA/QC Director – Fairfield, NJ

Summary:

The QA/QC Director is primarily responsible for the development and implementation of quality management systems. Establishing quality standards and procedures as well as monitor compliance and regulatory requirements.

Responsibilities

• To ensure that the production facility is operating at a high operational and compliance standard.
• Lead, coach and manage a team of chemists to ensure data integrity and performance to meet business objectives
• Monitor each department’s operations to ensure that all procedures are being adhered to and that only approved products or services are being delivered to the company’s clients.
• Oversee the entire department, ensuring that proper procedures are being followed when approving each product or service.
• Ensure that deadlines are met
• Train and develop colleagues
• Assist employees to solve problems, using quality management techniques
• Consult with the quality managers and other personnel to design quality strategies and goals for the department, which will be implemented by employees
• Help to promote the implementation of quality systems throughout the company
• Develop and implement policies relating to all operations in accordance with company objectives. Ensure these policies are adhered to by personnel under your supervision and that appropriate records are kept for future reference
• Keep management informed on product quality and any concerns that may influence this measure, such as complaints from customers or suppliers, etcetera
• Other duties assigned by Management

Education:

• Bachelor’s degree in a scientific discipline with a minimum of 10 years’ experience in quality management

Experience Requirements:

• Experienced with liquid manufacturing and packaging of Rx products.
• Experience with Empower 3
• Experience working in an FDA regulated environment
• Experience with ANDA and NDA submissions
• Experience with validations of processes, cleaning, analytical methods, facilities and equipment
• Knowledge of CFR & ICH Regulatory Guidelines
• Knowledge of cGMP processes and GDP.

Computer Skills:

• Microsoft Word
• Microsoft Excel
• Empower 3

Other Requirements:

• Has significant technical knowledge of quality management principles.
• In depth knowledge of all laboratory equipment, practices, and procedures
• Ability to think logically and independently
• Demonstrated managerial abilities
• Problem analysis, solving and resolution skills
• Has excellent oral and written skills
• Has excellent interpersonal skills
• Is self motivated
• Has a very high attention to detail
• Has a positive attitude
• Must speak, read, and write in English

**Data Quality Assurance Lead Director (Hybrid)**
Technology & Business Enablement (T&BE) empowers Citi to achieve its day-to-day operational and long-term growth goals, enabling execution of Citi's strategy by providing technical solutions and infrastructure across the firm.
T&BE is responsible for the technology and infrastructure colleagues use, defending the firm from cyber-attacks, and processing every loan, transaction, trade, and customer request that comes into the firm. Our teams re-engineer the client and partner experience to deliver excellence through secure, reliable and controlled services, focused on making Citi a simpler bank that is easier to work and do business with. Another critical component of T&BE is the Enterprise Data Office which is responsible for overseeing Citi's Data strategy and implementation. This includes driving consistent standards and capabilities for enterprise data management.
Within T&BE, the Chief Operating Office (T&BE COO) drives a strong focus on risk and controls, compliance and value across T&BE organization and oversees Controls, Analytics and Decision Management, Quality Assurance, Regulatory Management, Data and Transformation for Technology, as well as Business Execution for our Technology, and Foundational Services functions.
The T&BE Quality Assurance (QA) function sits within T&BE COO organization and is responsible to provide independent and objective assessment on the effectiveness, quality and timeliness of the remediation of high severity issues and Transformation regulatory commitments across T&BE globally.
The Data Quality Assurance Lead will be a key member of the T&BE QA team. This role will report to the T&BE Data Quality Assurance Head. The Data Quality Assurance Lead will be instrumental in establishing and implementing quality assurance processes within the Enterprise Data Office globally.
**Key Responsibilities:**
Quality Assurance Strategy
+ Execute the QA mandate and provide oversight to drive consistent and clear QA processes, monitoring, reporting and escalation.
+ Maintain common QA standards, procedures and governance processes to create and maintain consistent and best in class QA protocols.
+ Review the identified issues, gain agreement on planned actions and provide strategic remediation paths for key issues.
+ Partner across T&BE, 1st line Risk and Controls, 2nd and 3rd line functions to drive accountability to deliver on remediation activities.
+ Define and implement future state strategies over Data Quality Assurance activities.
Quality Assurance Processes
+ Proactively support T&BE Data Quality Assurance Head and T&BE Head of Quality Assurance in identifying and executing strategic decisions and initiatives.
+ Lead a QA team and ensure on-time and quality execution of QA reviews across assigned internal and regulatory issues portfolio in conformance with T&BE QA procedure. Supervise the team to ensure quality and concise QA workpapers and traceability matrix documentation. Ensure QA workflow tool is updated with accurate and complete information.
+ Demonstrate expertise of data management, risk and control and in-depth knowledge of the internal and regulatory issue remediation, Consent Order plan and interdependencies with other Issues/Regulatory Commitments.
+ Supervise allocated resources and budgeted hours for the assigned portfolio to ensure any potential deviations is addressed and provide timely feedback in QA workflow tool.
+ Drive positive change for T&BE to strengthen its risk management and control environment through successful Issue/RBCM remediation.
+ Escalate any concerns/observations to relevant senior stakeholders and support them to identify solutions.
+ Publish quality and on-time QA status reporting to T&BE leadership.
+ Publish quality and on-time QA Clearance/Non-objection memo.
+ Manage and mentor QA team members and support their career development within Citi.
+ Drive improvement initiatives to improve the quality and efficiency of the function.
+ This is a global role involving interaction with stakeholders across APAC, EMEA and NAM. Work timings accordingly will remain flexible.
**Qualifications:**
+ 15+ years of extensive experience in data management, risk and control, supervision, issues management QA / control and monitoring processes.
+ Specific subject matter expertise regarding data management, data governance, and risk and control disciplines within Data and/or Technology processes.
+ Ability to effectively drive and lead change in an organization with Citigroup's size.
+ Meaningful knowledge of the risk management framework, including risk identification, risk appetite and strategy, risk-related decisions, processes and controls, risk analytics and governance.
+ Experience working horizontally across an organization and participating in enterprise-wide implementations of major policy and relevant risk programs.
+ Comprehensive knowledge and understanding of strategic elements of financial, operational, technical, and regulatory environment across the company.
+ Experience in regulatory data remediation activities.
+ Broad understanding of relevant banking regulation and supervisory expectations for large complex financial institutions.
+ Well-developed listening skills and a strong ability to engage at the executive management level by providing proactive support and advice on a variety of risk matters.
+ Superior oral and written communication skills, and in particular ability to articulate and influence senior stake holders.
+ Strong leadership skills and demonstrated experience with a proven track record in driving positive and sustained change.
+ Proven record of effective communication with regulatory bodies and awareness of relevant banking regulation and supervisory expectations.
+ Ability to lead by example, strong influential and interpersonal skills, used to deliver results and push the organization agenda in a complex environment.
+ Strong ability to engage at the senior management level and demonstrated communication experience at different levels of organization.
**Education** :
Bachelor's/University degree, Master's degree preferred
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**Job Family Group:**
Controls Governance & Oversight
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**Job Family:**
Quality Assurance, Monitoring & Testing
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**Time Type:**
Full time
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**Primary Location:**
New York New York United States
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**Primary Location Full Time Salary Range:**
$170,000.00 - $300,000.00
In addition to salary, Citi's offerings may also include, for eligible employees, discretionary and formulaic incentive and retention awards. Citi offers competitive employee benefits, including: medical, dental & vision coverage; 401(k); life, accident, and disability insurance; and wellness programs. Citi also offers paid time off packages, including planned time off (vacation), unplanned time off (sick leave), and paid holidays. For additional information regarding Citi employee benefits, please visit citibenefits.com. Available offerings may vary by jurisdiction, job level, and date of hire.
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**Most Relevant Skills**
Analytical Thinking, Assurance Strategy, Communication, Constructive Debate, Controls Assessment, Controls Lifecycle, Policy and Procedure, Risk Remediation, Stakeholder Management.
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**Other Relevant Skills**
For complementary skills, please see above and/or contact the recruiter.
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**Anticipated Posting Close Date:**
Sep 15, 2025
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_Citi is an equal opportunity employer, and qualified candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law._
_If you are a person with a disability and need a reasonable accommodation to use our search tools and/or apply for a career opportunity review Accessibility at Citi ( ._
_View Citi's EEO Policy Statement ( and the Know Your Rights ( poster._
Citi is an equal opportunity and affirmative action employer.
Minority/Female/Veteran/Individuals with Disabilities/Sexual Orientation/Gender Identity.

QA/QC Director Fairfield, NJ

Summary:

The QA/QC Director is primarily responsible for the development and implementation of quality management systems. Establishing quality standards and procedures as well as monitor compliance and regulatory requirements.

Responsibilities

• To ensure that the production facility is operating at a high operational and compliance standard.
• Lead, coach and manage a team of chemists to ensure data integrity and performance to meet business objectives
• Monitor each departments operations to ensure that all procedures are being adhered to and that only approved products or services are being delivered to the companys clients.
• Oversee the entire department, ensuring that proper procedures are being followed when approving each product or service.
• Ensure that deadlines are met
• Train and develop colleagues
• Assist employees to solve problems, using quality management techniques
• Consult with the quality managers and other personnel to design quality strategies and goals for the department, which will be implemented by employees
• Help to promote the implementation of quality systems throughout the company
• Develop and implement policies relating to all operations in accordance with company objectives. Ensure these policies are adhered to by personnel under your supervision and that appropriate records are kept for future reference
• Keep management informed on product quality and any concerns that may influence this measure, such as complaints from customers or suppliers, etcetera
• Other duties assigned by Management

Education:

• Bachelors degree in a scientific discipline with a minimum of 10 years experience in quality management

Experience Requirements:

• Experienced with liquid manufacturing and packaging of Rx products.
• Experience with Empower 3
• Experience working in an FDA regulated environment
• Experience with ANDA and NDA submissions
• Experience with validations of processes, cleaning, analytical methods, facilities and equipment
• Knowledge of CFR & ICH Regulatory Guidelines
• Knowledge of cGMP processes and GDP.

Computer Skills:

• Microsoft Word
• Microsoft Excel
• Empower 3

Other Requirements:

• Has significant technical knowledge of quality management principles.
• In depth knowledge of all laboratory equipment, practices, and procedures
• Ability to think logically and independently
• Demonstrated managerial abilities
• Problem analysis, solving and resolution skills
• Has excellent oral and written skills
• Has excellent interpersonal skills
• Is self motivated
• Has a very high attention to detail
• Has a positive attitude
• Must speak, read, and write in English

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses
worldwide. As an Associate Director of Quality Assurance, you are responsible for:
**Job** **Responsibilities:**
- Serve as a lead quality engineer for medical device combination product development projects, with a strong emphasis on design control and risk management activities.
- Oversee design control, risk management, platform, or statistical techniques improvement initiatives
- Collaborate with device engineering on new combination product development, supporting design verification, validation, and transfer activities.
- Contribute to quality improvement initiatives and ensure compliance with relevant regulations and standards, including FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and Gilead's quality system requirements.
- Plan and implement approved quality improvement action items and deliverables.
- Interface with internal stakeholders, contract manufacturers, and suppliers to resolve complex technical issues related to drug-device combination products, processes, and quality.
- Act as an escalation point for complex and high-impact quality issues, concerns, and decisions.
- Support strategic relationships with internal cross-functional teams and contract manufacturing organizations (CMOs).
- Provide guidance and impact assessments for change controls, including Design History File (DHF) and Risk Management File (RMF) assessments.
- Develop and/or review controlled documents (e.g., protocols, reports, plans, risk analyses, specifications, test methods).
**Basic Qualifications** **:**
- Bachelor's degree in engineering or a scientific discipline with 10+ years of relevant experience, OR a Master's degree in a relevant field with 8+ years of relevant experience.
- Demonstrated knowledge and experience in quality assurance for the development of medical devices and/or drug-device combination products.
**Preferred Qualifications:**
- Prior experience with combination products (e.g., autoinjectors, co-packed kits, pre-filled syringes) is preferred.
- Strong project management and process improvement skills.
- Understanding of domestic and international quality system regulations and the ability to drive continuous improvement.
- Possess a strong foundation in statistical techniques (e.g., normality tests, capability analysis, tolerance intervals), test method validation (MSA, Gage R&R), and risk management principles per ISO 14971, including FMEA and systems analysis. Expertise in one of these areas is required
- Ability to develop and improve complex concepts, techniques, standards, and new applications based on quality principles and theories.
- Strong knowledge of medical devices and or combination products manufacturing.
- Excellent verbal, written, and interpersonal communication skills
The salary range for this position is: $182,070.00 - $235,620.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
**For jobs in the United States:**
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' ( poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT ( RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.
Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
This position is part of the Quality department located in Fargo, ND and will be On-site. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Quality Assurance Department and report to the VP of Quality responsible for creating and executing on the Quality Assurance Strategy.
Job Responsibilities:
+ The creation, implementation and maintenance of all Quality and release processes in compliance with all foreign and domestic regulatory and statutory requirements. This individual will help to provide the strategic direction and vision as well as the tactical leadership necessary to consistently improve.
+ Supports the company in assuring it is operating in accordance with applicable regulations, standards and guidance related to clinical and commercial activities and helps maintains positive audit results.
+ Serve as the site's primary contact with both customers and regulatory agencies regarding quality/compliance issues and Negotiate Quality Agreements
+ Develop and enhance phase appropriate QMS programs that comply with industry standards for development through commercialization GMPs including but not limited to establishment of quality agreements, management of lot review audit programs, Implementation of QA review for Master and Executed Batch Records, development and oversight of processes supporting inspection and release of incoming raw materials, and implementation of in-process quality assurance review
+ Oversee and manage all aspects of quality functions for quality systems Product Complaints, Product Quality Review, Lot Disposition (raw materials to finished Product release)
+ Establishes and implements metrics (process capability, control charts, measurement quality, etc.) for monitoring system effectiveness to enable sound quality decisions and to improve quality.
+ Provide leadership and management to direct reports including day-to-day supervision, performance management, training, and planning while leveraging team member skills and abilities to ensure goals are achieved.
Qualifications:
+ 10+ years of relevant experience in a quality position, required with a minimum of 3 years in a managerial position.
+ Experience with final drug product manufacturing with incoming Quality Management Systems, Quality Assurance and regulatory audits required.
+ Bachelor of Science required; life science related field, preferred.
+ Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application, required
+ Strong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics (210, 211, and 610 CFR and EudraLex Vol. 4), including regulatory inspection or support experience, preferred
+ Ability to manage priorities, track progress of key projects, and provide updates to leadership as required.
It would be a plus if you also possess previous experience in:
+ Experience working in a matrix environment.
+ Experience implementing and executing on cGMP Quality Strategy
#LI-GC1
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
The U.S. EEO posters are available here ( .
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: or .

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Quality
**Job Sub** **Function:**
Quality Assurance
**Job Category:**
People Leader
**All Job Posting Locations:**
Gurabo, Puerto Rico, United States of America
**Job Description:**
Johnson & Johnson is currently recruiting for a **Director, Quality Assurance (Parenteral)!** This position will be located in Gurabo, PR.
_At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healllthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at_ _ _._
**Position Summary:**
The Quality Assurance (QA) Director will be accountable for providing technical knowledge, direction, and support of assigned products including areas, such as Chemistry, Technology Transfer, Microbiology Laboratories and the Quality Assurance for the manufacture and final disposition of products. Responsible for ensuring the conformance of manufacturing, packaging and product transfers activities with the current Good Manufacturing Practices, Janssen policies, standards and internal procedures.
The QA Director will provide technical and compliance knowledge to ensure that the manufacture and management of the products have the appropriate systems and testing processes in place in compliance with cGMP and GLP, corporate standards, federal and international regulations, and industry practices. Supports the review and approval of procedures and specifications, significant investigations, product reviews, equipment/facility modification, and validation documents to ensure regulatory compliance. Leads discussions on solutions to problems with manufacturing processes, in-process product, final product release and product complaints to ensure timely resolution. Serves as the back up to the Site Quality Head of the Gurabo site.
**Key Responsibilities:**
+ Acts as the Parenteral site Management Representative in line with Johnson & Johnson Quality Policies and Health Authorities regulations.
+ Monitors and reviews the quality management system for compliance, effectiveness, and improvement opportunities.
+ Promotes awareness of regulatory requirements and monitors key quality performance measures.
+ Manages the CAPA system, reports to management, and initiates corrective/preventive actions.
+ Develops strategies for cGMP compliance, budget management, and operational structure for business needs.
+ Participates in product transfer teams to ensure compliance with cGMP and internal procedures.
+ Collaborates with Product and Analytical Development teams to address issues and schedule activities.
+ Supports product and technology launches and participates in stage gate reviews.
+ Partners with Compliance Team for internal audits and handles customer complaints in compliance with cGMP.
+ Leads Quality Risk Assessment exercises and ensures consistent manufacturing practices across sites.
+ Supervises, coaches, and develops assigned personnel; ensures training and performance assessments.
+ Recommends modifications to policies and participates in achieving strategic goals.
+ Observes and makes sure compliance with all company policies and regulations.
+ Supports Process Excellence Projects, ISO 14001 improvement, and Environmental and Safety initiatives.
+ Serves as the Site QA Qualified Person per China Drugs GMP Regulations.
**Qualifications - External**
**Education:**
A minimum of a Bachelor's or equivalent University degree with a focus in Chemistry, Pharmacy, Biochemistry, Chemical Engineering or related Science or Engineering preferred. Master's in science or Engineering is highly preferred.
**Experience and Skills:**
**Required:**
+ Minimum of 12years of experience in the pharmaceutical industry, ten of them in a parenteral operation.
+ Minimum eight (8) years of experience in a managerial role. Five (5) years of experience in Quality leadership role is required.
+ Knowledge in equipment and process validation, environmental conditions and monitoring, aseptic processing, technology transfer, release, regulatory, lyophilization and troubleshooting of aseptic and combination products.
+ Vast knowledge of lyophilization and sterilization processes preferred.
+ Shown experience in implementing quality systems. Develops and implements strategy for cGMP's compliance for the site.
+ Experience in regulated environmental (FDA, MHRA) and other worldwide regulatory agencies and management of regulatory inspections.
+ The position requires skills in problem-solving and analysis, including interpreting complex documents and preparing presentations. Candidates should be able to work both independently and in teams, follow technical instructions, meet deadlines, make precise decisions quickly, and possess strong interpersonal skills.
**Other:**
+ Be fluent in Spanish and English and must have excellent ability to write in English and Spanish.
+ Must exercise judgement on the resolution of production problems to meet company standards for quality, cost and critical success factors.
+ Availability for traveling, working irregular shifts, frequently requires working extended hours, and might be required to work on holidays and weekends.
+ Be proficient in the use of MS Office applications: Word, Excel, Power Point, and Internet.
+ Knowledge in process excellence and project management tools.
+ 10% Travel Requirements
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Quality
**Job Sub** **Function:**
Quality Assurance
**Job Category:**
People Leader
**All Job Posting Locations:**
Raritan, New Jersey, United States of America
**Job Description:**
Johnson & Johnson Innovative Medicines is recruiting for the Director, Quality Assurance Operations- CAR-T Manufacturing. This position will be based in Raritan, NJ.
_At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Johnson & Johnson Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiopulmonary, and retina. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it._
Johnson & Johnson and Legend Biotech USA Inc, have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.
**Position Summary:**
The Director, Quality Assurance Operations, Raritan CAR-T leads and handles all aspects of Quality Operations in support of the Raritan CAR-T manufacturing site, in full compliance with established cGMP, J&J and JSC requirements. Functions and activities include Quality oversight of QA Incoming, QA Shop Floor, Batch Record Review, Drug Product Release, Cryopreservation, Lenti, and QCBB production facilities. Manages a team of people leaders and technical professionals within the QA based on assigned work, direction, mentoring and developing capabilities. Develops and implements long-term strategies, and execution of Quality programs.
We are seeking a dynamic and experienced Director, Quality Operations to join our team at Raritan CAR-T. In this pivotal role, you will be responsible for driving the Quality Operations strategy for our site, ensuring that all quality standards are met and maintained throughout our operations. The ideal candidate will possess strong leadership skills, a deep understanding of quality management systems, and a commitment to excellence in delivering safe and effective therapies to patients.
**Key Responsibilities:**
+ Develops, implements and drives a comprehensive Quality Operations strategy, aligned with site goals.
+ Leads the establishment and execution of quality objectives and key performance indicators (KPIs) that drive continuous improvement and operational excellence.
+ Proactively identifies recurring trends and implements a Right First Time program in collaboration with manufacturing and QC operations to reduce deviations and improve efficiency.
+ Ensure effective risk management practices are in place, including identification, assessment, and mitigation of quality-related risks. Provides leadership and direction to the Quality and Site Management Teams to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model.
+ Develops and champions an interpersonal culture that promotes behaviors that lead to outstanding business performance and organizational excellence.
+ Ensure effective risk management practices are in place, including identification, assessment, and mitigation of quality-related risks.
+ Responsible for appropriately staffing and developing the Quality Operations organization to meet budget and succession plans.
+ Leads launches of new products and technologies. Participates in product stage gate reviews representing Raritan site Quality Assurance.
+ Partners with the Compliance Team to prepare for and support Health Authority inspections at Raritan. Leads and hosts compliance audits. Serves as SME for QA operations to support all regulatory inspections.
+ Lead initiatives focused on process optimization, data-driven decision-making, and the application of quality improvement methodologies (e.g., Six Sigma, Lean).
+ Monitor industry trends and emerging best practices to innovate and enhance quality processes within the organization.
+ Ensures that all external customer complaints and internal complaints from affiliates are handled, evaluated and investigated in timely and effective manner, in conformance with cGMP's, Janssen Supply Chain Policies and Procedures.
**Qualifications - External**
**Education:**
A minimum of a bachelor's degree in Science is required, preferably in Biology, Microbiology, Chemistry, Pharmacy, Biochemistry, Chemical Engineering or related Science or Engineering.
**Required:**
+ Demonstrated experience building and leading exceptional Quality Assurance teams.
+ A minimum of 10 years relevant work experience, with 5 of those years managing a team of senior leaders and professionals within Quality Assurance.
+ Experience with implementing and coordinating GMP operations in a commercial manufacturing facility.
+ Experience leading process optimization initiatives, data-driven decision-making, and the application of quality improvement methodologies.
+ Monitor industry trends and emerging best practices to innovate and enhance quality processes within the organization.
+ Knowledgeable of Quality Risk Management concepts.
+ Experience in regulated environment (FDA, EMA) and other worldwide regulatory agencies and regulatory inspections.
+ Comfortable speaking and interacting with inspectors and senior leadership
+ Excellent communication, interpersonal relation, presentation, collaboration, and influencing skills.
**Preferred:**
+ Significant experience with Advanced Therapies is preferred.
**Other:**
+ This position may require up to 10% domestic travel
+ This position has an estimated annual salary of $146,000-$51,850  USD$< r>Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
_Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation,_ **_external applicants please contact us via_** **_ **_. internal employees contact AskGS to be directed to your accommodation resource._**
**The anticipated base pay range for this position is :**
146,000- 251,850  USD$< r>Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below.

**Current Saint Francis Employees - Please click HERE ( **to login and apply.**
Full Time
Days
Schedule: Monday - Friday | 8:00am - 5:00pm
Job Summary: The System Director of Quality Assurance plans and directs activities of the Quality Assurance areas of the Saint Francis Health System for the purpose of facilitating and improving disease management and clinical process outcomes.
Minimum Education: Bachelor's degree in Nursing or Health Care related field. Enrolled in or completion of a Master's degree in Business Administration, or Health Care related field.
Licensure, Registration and/or Certification: Certified Professional in Healthcare Quality (CPHQ) from National Association for Healthcare Quality (NAHQ).
Work Experience: Minimum 5 years Quality Assurance experience including 3 years Management experience.
Knowledge, Skills, and Abilities: Knowledge of performance improvement techniques and methods. Excellent communication skills, both written and verbal that present clear and concise information. Effective interpersonal skills. Strong leadership skills relative to motivating and developing multi-disciplinary teams to be successful. Sound ability to analyze complex issues and solve them creatively. Ability to utilize assertiveness, political intuitiveness, and be self-motivated. Strong ability to organize and prioritize work in an effective and efficient manner.
Essential Functions and Responsibilities: Identifies, oversees and assists with performance improvement projects throughout the saint Francis Health System. Provides data analysis and interpretation. Participates in entity special projects including retreat facilitation and planning, staff engagement facilitations and instruction and other special projects. Participates in Quality Improvement oversight and monitoring in all SFHS entities (Quality Reporting Structure, scorecards and the 'Blue Slide'). Directs strategic and operational elements of the Hospital Inpatient and Outpatient Quality Reporting program. Directs department operations.
Decision Making: Independent judgment in making decisions from many diversified alternatives that are subject to general review in final stages only.
Working Relationships: Direct Supervision of others. Works directly with patients and/or customers. Works with internal and/or external customers via telephone or face to face interaction. Works with other healthcare professionals and staff. Works frequently with individuals at Director level or above.
Special Job Dimensions: None.
Supplemental Information: This document generally describes the essential functions of the job and the physical demands required to perform the job. This compilation of essential functions and physical demands is not all inclusive nor does it prohibit the assignment of additional duties.
Quality Attainment/Outcomes Measurements - Yale Campus
Location:
Tulsa, Oklahoma 74136
**EOE Protected Veterans/Disability**