11,710 Head Of Quality jobs in the United States

About Avive:

Avive Solutions, Inc. ( is a growth stage Automated External Defibrillator (AED) company with a connected response system that is rapidly gaining market share. We are a mission driven team that is quite literally saving lives. Sudden Cardiac Arrest (SCA) is a leading cause of death in the United States, and we are on a mission to change that! We are a dynamic organization that builds elegant, creative solutions to solve complex problems. Ultimately, our mission is for all cardiac arrest victims to have rapid access to life-saving defibrillation.

Avive is taking a fresh approach to addressing this decades-old problem by innovating AED technology, coupled with a first-of-its-kind software platform solution to enable a quicker and more streamlined response to SCA emergencies. We believe that this unique combination of deploying advanced - yet still accessible - hardware, and software, has the potential to revolutionize out-of-hospital cardiac arrest response and massively impact SCA survival rates.

Check out this short video that shows a glimpse of how our team is working to re-think cardiac arrest response and save lives! more about working at Avive: the Role:

We are seeking a Head of Quality to assume overall responsibility for ensuring high quality products and compliant quality management system processes to support clinical and commercial use of Company products. This person will serve as Quality System Management Representative, including hosting regulatory authority audits.

What You'll Do:

Leads the Quality team, accountable for the following areas:

Serves as Quality System Management Representative, and as such: 1.) Ensures processes needed for the quality management system are established, implemented and maintained. 2.) Reports to top management on quality system performance and any need for improvement. 3.) Ensures the promotion of awareness of regulatory and customer requirements throughout the organization. 4.) Runs quality system Management Review meetings including input and output generation.Ensures integration of quality system requirements into product design and development activities throughout the product life cycle with particular focus on risk management, verification/validation, and manufacturing controls.Maintains quality systems pertaining to areas including but not limited to document control, quality audits, supplier evaluation, equipment calibration and maintenance, product inspection/testing, nonconforming part control, corrective/preventive action, and risk management.Evaluates, audits, approves, and monitors product and service suppliers. Coordinates supplier corrective actions as appropriate to ensure that quality requirements are met. Maintains supplier evaluation and approved vendor files.Manages quality system training process. Identifies personnel training requirements. Maintains training matrices and publishes status reports to ensure training requirements are met.Manages Corrective and Preventive Action (CAPA) process to ensure on-time completion of required activities. Verifies and validates action effectiveness by collecting and analyzing quality system data.Manages internal and external quality audits to ensure quality system compliance and effectiveness. Plans and coordinates audits, prepares audit responses, and coordinates corrective actions.Establishes quality inspection procedures and statistical sampling plans. Ensures that appropriate inspection and test equipment is obtained and properly used for inspections and tests.Leads nonconforming product review activities to efficiently disposition affected material. Investigates causes of nonconforming products and implements effective corrective actions.Maintains various lists, logs and tracking systems related to documents and records. Performs and documents product complaint investigations. Supports regulatory agency reporting as assigned.Analyzes product complaint and post market surveillance data and prepares summary reports.Ensures compliance with changing applicable state, federal, and international regulations and standards.

Required Skill & Experience:

* BS Engineering or life sciences required
* Minimum ten (10) years of medical product experience.
* Experience required in design, implementation and maintenance of quality management systems for medical product development, manufacturing, distribution, and post market surveillance.
* Proficiency required with international medical product regulations and standards.
* Proficiency required with application of statistical techniques for manufacturing and quality systems.
* Proficient with word processing, spreadsheet, presentation and document management software.
* Languages: Full professional proficiency in English is minimum requirement.

Bonus Points For:

* Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other people.
* Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential.
* Good organizational and oral and written communication skills, including ability to represent the Company to both internal and external audiences.
* Proven track record of organizing, hiring, and developing highly effective teams.

Equal Employment Opportunity

It is the policy of the company to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, the company will provide reasonable accommodations for qualified individuals with disabilities.

NOTE: This Job Description in no way states or implies that these are the only duties or functions to be performed by the incumbent. Personnel are required to follow any other job-related instructions and to perform any other job-related duties/functions requested by their supervisor.

Anticipated salary range: $180,000 - $220,000

About Wing:

Wing offers drone delivery as a safe, fast, and sustainable solution for last mile logistics. Consumer appetites for on-demand services are increasing, but current delivery methods are inefficient, costly, and contribute to road accidents and air pollution. Wing's fleet of highly automated delivery drones can transport small packages directly from businesses to homes on-demand, in minutes. We design, build, and operate our aircraft, and offer drone delivery services on three continents. Our technology is designed to be easy to integrate into existing delivery and logistics networks, offering a scalable drone delivery solution for a broad range of businesses. Wing is a part of Google's parent company, Alphabet, and our mission is to create the preferred means of delivery for the planet. If you're ready to do the greatest work of your life, come join us.

About the Role:

Wing is looking for a Head of Quality Engineering to join our Quality Manufacturing Team based in Palo Alto, California . The ideal candidate has a proven quality team management experience, demonstrated knowledge of industry best practices in product quality and supplier quality, and the ability to deliver results as part of a dynamic, cross-functional team.

What You'll Do:

• Own quality function from supplier quality to CM's manufacturing quality, field/customer quality experience will be a plus
• Mentor quality team members, and engage with leadership as focal point for escalations
• Manage quality team performance, develop team members
• Manage product lifecycle from quality perspective from NPI to mass production for all projects
• Manage CM's and component supplier's manufacturing quality performance
• Manage quality escalations working closely with other functional teams
• Drive CM and suppliers for continuous improvement
• Identify potential suppliers, audit their quality system, and assess their manufacturing processes by applying knowledge of materials, product design, manufacturing, assembly, testing etc.
• Responsible for setting and executing advanced quality plans including incoming, in process and outgoing quality checks for assemblies or components.
• Work with FAA to achieve Part21 certification (production certification), create the quality documentation as needed and implement at production sites
• Define and review specification requirements for fit, function, and reliability by working together with Wing Mechanical Engineering, Hardware Engineering and reliability team
• Coordinate with contributing groups to ensure updates are processed on schedule.
• Work with massive amounts of data and measure quality
• Initiate, recommend or provide solutions to non-compliance
• Manage CM's SMT and assembly line qualifications in different stages of product life cycle

What You'll Need:

• 15+ years of experience in a quality or reliability engineering role, overseeing the product lifecycle from New Product Introduction (NPI) to high-volume manufacturing.
• 8+ years of experience in leading and managing teams.
• Bachelor's or higher degree in Mechanical Engineering, Electrical Engineering, or a closely related field; equivalent experience may be considered.
• Strong background in manufacturing, with a proven ability to develop scalable and robust processes for new products. This includes experience with process qualification, process quality control, and line qualification under tight deadlines.
• Demonstrated expertise in driving engineering requirements and implementing continuous quality improvement initiatives at both vendors and contract manufacturers.
• Excellent communication skills and the ability to interact effectively with cross-functional teams and senior management.
• Deep understanding of Geometric Dimensioning and Tolerancing (GD&T), tolerance stack-up analysis, and design principles.
• Proficient in identifying when additional support is required and taking the initiative to seek assistance.
• Hands-on experience with mechanical systems, injection molding, machining, and casting processes.
• Ability to establish and implement Statistical Process Control (SPC) systems, including process capability (Cp) and process capability index (Cpk) analysis.
• Familiarity with Design of Experiments (DOE) methodologies, statistical analysis techniques, and statistical software tools such as Minitab and JMP.
• Preferred with Six Sigma Green or Black Belt certification

The US base salary range for this full-time position is the salary range below + bonus + equity + benefits. Wing's salary ranges are determined by role, level, and location. Your recruiter can share more about the specific salary range for your location during the hiring process.

Salary Range

$251,000-$292,000 USD

Wing is an equal opportunity employer and it is Wing's policy to comply with all applicable national, state and local laws pertaining to nondiscrimination and equal opportunity. Employment at Wing is based solely on a person's merit and qualifications directly related to professional competence. Wing does not discriminate against any employee or applicant because of race, creed, color, religion, gender, sexual orientation, gender identity/expression, national origin, disability, age, genetic information, veteran status, marital status, pregnancy or related condition (including breastfeeding), or any other basis protected by law.

If you have a need that requires accommodation during the interview process due to a disability or special need, please let us know by completing our Candidate Accommodations Request Form.

About Avive:

Avive Solutions, Inc. ( is a growth stage Automated External Defibrillator (AED) company with a connected response system that is rapidly gaining market share. We are a mission driven team that is quite literally saving lives. Sudden Cardiac Arrest (SCA) is a leading cause of death in the United States, and we are on a mission to change that! We are a dynamic organization that builds elegant, creative solutions to solve complex problems. Ultimately, our mission is for all cardiac arrest victims to have rapid access to life-saving defibrillation.

Avive is taking a fresh approach to addressing this decades-old problem by innovating AED technology, coupled with a first-of-its-kind software platform solution to enable a quicker and more streamlined response to SCA emergencies. We believe that this unique combination of deploying advanced - yet still accessible - hardware, and software, has the potential to revolutionize out-of-hospital cardiac arrest response and massively impact SCA survival rates.

Check out this short video that shows a glimpse of how our team is working to re-think cardiac arrest response and save lives! more about working at Avive: the Role:

We are seeking a Head of Quality to assume overall responsibility for ensuring high quality products and compliant quality management system processes to support clinical and commercial use of Company products. This person will serve as Quality System Management Representative, including hosting regulatory authority audits.

What You'll Do:

Leads the Quality team, accountable for the following areas:


• Serves as Quality System Management Representative, and as such: 1.) Ensures processes needed for the quality management system are established, implemented and maintained. 2.) Reports to top management on quality system performance and any need for improvement. 3.) Ensures the promotion of awareness of regulatory and customer requirements throughout the organization. 4.) Runs quality system Management Review meetings including input and output generation.
• Ensures integration of quality system requirements into product design and development activities throughout the product life cycle with particular focus on risk management, verification/validation, and manufacturing controls.
• Maintains quality systems pertaining to areas including but not limited to document control, quality audits, supplier evaluation, equipment calibration and maintenance, product inspection/testing, nonconforming part control, corrective/preventive action, and risk management.
• Evaluates, audits, approves, and monitors product and service suppliers. Coordinates supplier corrective actions as appropriate to ensure that quality requirements are met. Maintains supplier evaluation and approved vendor files.
• Manages quality system training process. Identifies personnel training requirements. Maintains training matrices and publishes status reports to ensure training requirements are met.
• Manages Corrective and Preventive Action (CAPA) process to ensure on-time completion of required activities. Verifies and validates action effectiveness by collecting and analyzing quality system data.
• Manages internal and external quality audits to ensure quality system compliance and effectiveness. Plans and coordinates audits, prepares audit responses, and coordinates corrective actions.
• Establishes quality inspection procedures and statistical sampling plans. Ensures that appropriate inspection and test equipment is obtained and properly used for inspections and tests.
• Leads nonconforming product review activities to efficiently disposition affected material. Investigates causes of nonconforming products and implements effective corrective actions.
• Maintains various lists, logs and tracking systems related to documents and records.
• Performs and documents product complaint investigations. Supports regulatory agency reporting as assigned.
• Analyzes product complaint and post market surveillance data and prepares summary reports.
• Ensures compliance with changing applicable state, federal, and international regulations and standards.

Required Skill & Experience:

• BS Engineering or life sciences required
• Minimum ten (10) years of medical product experience.
• Experience required in design, implementation and maintenance of quality management systems for medical product development, manufacturing, distribution, and post market surveillance.
• Proficiency required with international medical product regulations and standards.
• Proficiency required with application of statistical techniques for manufacturing and quality systems.
• Proficient with word processing, spreadsheet, presentation and document management software.
• Languages: Full professional proficiency in English is minimum requirement.

Bonus Points For:

• Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other people.
• Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential.
• Good organizational and oral and written communication skills, including ability to represent the Company to both internal and external audiences.
• Proven track record of organizing, hiring, and developing highly effective teams.

Equal Employment Opportunity

It is the policy of the company to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, the company will provide reasonable accommodations for qualified individuals with disabilities.

NOTE: This Job Description in no way states or implies that these are the only duties or functions to be performed by the incumbent. Personnel are required to follow any other job-related instructions and to perform any other job-related duties/functions requested by their supervisor.

Anticipated salary range: $180,000 - $220,000

Recognized as the No. 1 site trusted by real estate professionals, Realtor.com has been at the forefront of online real estate for over 25 years, connecting buyers, sellers, and renters with trusted insights and expert guidance to find their perfect home. Through its robust suite of tools, Realtor.com not only makes a significant impact on the real estate industry at large, but for consumers, navigating the biggest purchase they will make in their life, by providing a user experience that is easy to use, easy to understand, and most of all, easy to make decisions.

Join us on our mission to empower more people to find their way home by breaking barriers to entry, making the right connections, and building confidence through expert guidance.

About Realtor.com

At Realtor.com, we help tens of millions of people make informed real estate decisions with confidence. As our platform grows, so does our ambition to deliver new features quickly while upholding the highest standards of quality. We are a technology-driven company where quality is not just a goal, but a shared responsibility across all engineering teams. You will play a central role in shaping how we achieve quality at speed and scale.

The Opportunity

We are searching for a Head of Quality who will transform Realtor.com's approach to quality from embedded QA to a model focused on enablement, automation, and transparency. This leader will empower every engineering team to own and accelerate quality. You will build the frameworks, processes, and culture that make quality repeatable and measurable across our company, with a strong emphasis on modern, AI-driven solutions.

What You'll Do

* Define and lead the shift from embedded QA to an enablement-focused quality model
* Champion an AI-first approach, introducing and scaling new QA tools and automation across engineering teams
* Audit all current QA processes and vendors, recommending what to evolve, keep, or replace
* Build frameworks, infrastructure, and best practices that make quality self-service and repeatable
* Make quality metrics and dashboards highly visible so teams can own and improve their results
* Promote a culture of accountability, continuous improvement, and knowledge sharing around quality

Who You Are

* 12+ years in quality engineering or test automation roles, including 7+ years of management experience, and experience enabling large product teams
* Bachelor's degree or equivalent experience
* Proven track record transforming QA organizations and modernizing processes and tooling
* Deep expertise with automation frameworks, CI/CD pipelines, and cloud-based testing
* Hands-on experience evaluating and deploying AI-driven QA tools
* Strong analytical skills with a focus on metrics, transparency, and process improvement
* Collaborative, influential, and comfortable leading change across engineering organizations
* Effective mentor and communicator, able to drive adoption of new practices

Why Realtor.com?

At Realtor.com, you will shape how our users experience one of the most important transactions of their lives. Here, you will have a mandate to reimagine how quality is achieved at scale, with the support of an organization that values innovation, transparency, and rapid delivery. If you are energized by the challenge of transforming quality for a growing platform, and you believe the future of quality is AI-driven, transparent, and collaborative, this is the place to make a lasting impact.

Do the best work of your life at Realtor.com

Here, you'll partner with a diverse team of experts as you use leading-edge tech to empower everyone to meet a crucial goal: finding their way home. And you'll find your way home too. People are our foundation-the core that drives us passionately forward. At Realtor.com, you'll bring your full self to work as you innovate with speed, serve our consumers, and champion your teammates. In return, we'll provide you with a warm, welcoming, and inclusive culture; intellectual challenges; and the development opportunities you need to grow.

Diversity is important to us, therefore, Realtor.com is an Equal Opportunity Employer regardless of age, color, national origin, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, marital status, status as a disabled veteran and/or veteran of the Vietnam Era or any other characteristic protected by federal, state or local law. In addition, Realtor.com will provide reasonable accommodations for otherwise qualified disabled individuals.

Head of Quality

About Climb:

Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. Our product candidates include budoprutug, an anti-CD19 monoclonal antibody that presents us with an exciting opportunity given its broad potential applicability across a number of B-cell mediated diseases, including membranous nephropathy, immune thrombocytopenia, and systemic lupus erythematosus, and CLYM116, an anti-APRIL monoclonal antibody in preclinical development for IgA nephropathy.

At Climb Bio, our team has a knack for seeing what no one else sees-and a drive to achieve results no one expects. We are seeking a highly motivated Head of Quality. This role will initially report to the CEO. As Head of Quality you will lead all quality assurance activities, ensuring compliance with regulatory standards and overseeing quality operations for the company. This is an exciting opportunity to shape and grow the Quality function at small and growing organization.

Key Responsibilities:

* Develop, implement, and oversee the company's Quality Management System (QMS).
* Ensure compliance with FDA, EMA, and other relevant regulatory guidelines.
* Oversee quality operations including GMP, GLP, and GCP compliance for clinical-stage biologics.
* Lead internal audits and manage external audits of clinical sites, laboratories, and CDMOs/CROs.
* Partner cross-functionally with clinical, regulatory, and manufacturing teams to align on quality initiatives.
* Provide strategic input into regulatory filings and support interactions with health authorities for inspection readiness.
* Conduct risk assessments and implement corrective and preventive action plans (CAPAs).
* Develop and deliver quality training for employees and external partners.

Qualifications:

* Bachelor's degree in Life Sciences or related field; advanced degree preferred.
* 10+ years of quality assurance experience in biotechnology/pharmaceutical industry, including experience in phase 1 through commercialization.
* Prior experience in senior level quality role within a biotechnology company
* Expertise in biologics is preferred
* Comprehensive knowledge of regulatory requirements (FDA, EMA) and quality guidelines (ICH, GMP, GCP, GLP).
* Demonstrated leadership in managing quality assurance functions and QMS.
* Experience conducting and managing audits and inspections.
* Exceptional problem-solving and communication skills, and the ability to operate in a collaborative and fast-paced environment.

This position will be based out of our Wellesley, MA office. Base salary offered may vary depending on the individual's skills, experience, and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, Life & Disability, 401k company match, generous paid time off, and equity.

Qualified candidates are encouraged to forward their resumes to (email protected)

Apply now

Climb is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, and disability or any other federal, state, provincial or local protected ground.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Director- Site Quality Head

The Opportunity

Abbott Diabetes Care has an opportunity for a Director - Site Quality Head. The Director leads strategy, management and support for global supplier quality associated with the division. Areas include suppliers (parts and services), Third Party Manufacturers (TPM), and Original Equipment Manufacturers (OEM), service providers and consultants. Establishes quality systems and plans for supplier controls to assure design, development and manufacture of the highest quality products to exceed customer requirements. Interfaces with outside regulatory agencies.

What You'll Work On

* Champions quality and compliance through awareness of requirements, trends and other external influencing factors especially in the area of supplier management.
* Builds strategic partnerships with internal and external stakeholders to further departmental and organizational objectives.
* Establishes a progressive supplier quality vision and strategy by recognizing situations and anticipating at a broad industry level and influences strategic decision making beyond own functional area.
* Develops operational strategy that comprehends and anticipates external compliance and regulatory requirements.
* Develops supplier quality strategy and planning that enables top-line growth and margin improvement.
* Establish Supplier Quality Systems that follow global regulatory requirements and meet business needs.
* Recruits, coaches and develops talent.
* Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
* Management of supplier audits, divisional budget, qualification, incident resolution, metric reporting and validation for division products and parts (e.g. meters, sensor assemblies and accessories).
* Third Party management of domestic and international sites for finished device manufacturing including yield and quality data reports, finished device acceptance, validation, external inspections, incoming, equipment calibration and maintenance activities.
* Management of third party service providers for offsite inspections and miscellaneous quality activities.
* Managing and acceptance of Third Party Manufacture of products (e.g. meters, readers, sensor devices and accessories).
* Analyzes data, makes decisions or provides recommendations to senior staff regarding supplier quality related crises.
* May be accountable for guiding cross functional resources to ensure program deliverables are effectively executed and that design control and quality system requirements are met.
* May support efficient decision making by Sr. Management by providing scenario analysis, risk identification and contingency plans.
* May implements project planning tools to support product development programs and ensures site wide communication of program status to drive engagement of staff.·
* Quality Management System (QMS) responsibility for TPM ensuring robust compliance and alignment with FDA, ISO, cGMP, etc
* Lead continuous improvement initiatives within the QMS framework.
* Manage TMP relationship with respect to Quality
* Support audits, respond to quality concerns, and provide data transparency.
* Ensure product release criteria meet specifications and customers' expectations.
* Coordinate CAPA (Corrective and Preventive Actions) processes for ADC
* Maintain audit readiness at all times.
* Support and lead divisional initiatives as required
* Influence the TPM organization to strive for excellence in everything they do

Required Qualifications

* Bachelors Degree or an equivalent combination of education and work experience.
* Minimum 10 years In regulated environment to develop competence to meet the skills and responsibilities of the position.
* Substantial knowledge of FDA and ISO Quality System Requirements and other applicable US Code of Federal Regulations for Devices.

APPLY NOW:

Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal

The base pay for this position is $147,300.00 - $294,700.00. In specific locations, the pay range may vary from the range posted.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
**Director- Site Quality Head**
**The Opportunity**
Abbott Diabetes Care has an opportunity for a Director - Site Quality Head. The Director leads strategy, management and support for global supplier quality associated with the division. Areas include suppliers (parts and services), Third Party Manufacturers (TPM), and Original Equipment Manufacturers (OEM), service providers and consultants. Establishes quality systems and plans for supplier controls to assure design, development and manufacture of the highest quality products to exceed customer requirements. Interfaces with outside regulatory agencies.
**What You'll Work On**
+ Champions quality and compliance through awareness of requirements, trends and other external influencing factors especially in the area of supplier management.
+ Builds strategic partnerships with internal and external stakeholders to further departmental and organizational objectives.
+ Establishes a progressive supplier quality vision and strategy by recognizing situations and anticipating at a broad industry level and influences strategic decision making beyond own functional area.
+ Develops operational strategy that comprehends and anticipates external compliance and regulatory requirements.
+ Develops supplier quality strategy and planning that enables top-line growth and margin improvement.
+ Establish Supplier Quality Systems that follow global regulatory requirements and meet business needs.
+ Recruits, coaches and develops talent.
+ Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
+ Management of supplier audits, divisional budget, qualification, incident resolution, metric reporting and validation for division products and parts (e.g. meters, sensor assemblies and accessories).
+ Third Party management of domestic and international sites for finished device manufacturing including yield and quality data reports, finished device acceptance, validation, external inspections, incoming, equipment calibration and maintenance activities.
+ Management of third party service providers for offsite inspections and miscellaneous quality activities.
+ Managing and acceptance of Third Party Manufacture of products (e.g. meters, readers, sensor devices and accessories).
+ Analyzes data, makes decisions or provides recommendations to senior staff regarding supplier quality related crises.
+ May be accountable for guiding cross functional resources to ensure program deliverables are effectively executed and that design control and quality system requirements are met.
+ May support efficient decision making by Sr. Management by providing scenario analysis, risk identification and contingency plans.
+ May implements project planning tools to support product development programs and ensures site wide communication of program status to drive engagement of staff.·
+ Quality Management System (QMS) responsibility for TPM ensuring robust compliance and alignment with FDA, ISO, cGMP, etc
+ Lead continuous improvement initiatives within the QMS framework.
+ Manage TMP relationship with respect to Quality
+ Support audits, respond to quality concerns, and provide data transparency.
+ Ensure product release criteria meet specifications and customers' expectations.
+ Coordinate CAPA (Corrective and Preventive Actions) processes for ADC
+ Maintain audit readiness at all times.
+ Support and lead divisional initiatives as required
+ Influence the TPM organization to strive for excellence in everything they do
**Required Qualifications**
+ Bachelors Degree or an equivalent combination of education and work experience.
+ Minimum 10 years In regulated environment to develop competence to meet the skills and responsibilities of the position.
+ Substantial knowledge of FDA and ISO Quality System Requirements and other applicable US Code of Federal Regulations for Devices.
APPLY NOW ( **:**
Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ( your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal
The base pay for this position is $147,300.00 - $294,700.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email

**Why Us?**

We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

**Job Description Summary**

The Site Head of Quality oversees and assures overall quality/integrity of pharmaceutical products manufactured and distributed based on cGMP regulations and industry standards. The Site Head of Quality will promote and exhibit the company's vision, mission, values and leadership behaviors. The Site Head of Quality will establish and lead the improvement and implementation of Quality Operations Procedures and systems across the manufacturing site. This is a leadership role within the Quality organization that will work closely with stakeholders to assure the implementation of harmonized Quality Operations Systems that will maintain quality and work efficiently with Operations and Supply Chain, The Site Head of Quality will ensure that Global Quality Operations Standards are maintained in a compliant status versus current GXP, keeping pace with current and future changes in regulations. This role will drive sharing of best Operations practices across company locations - sharing of significant issues and lessons learned, and incorporating these into revisions of Global Quality Policies and Standards.

**Job Description**

Scope of Authority

Oversight of the Quality Operations Function at the site

Key Accountabilities

Accountability

Quality Operations

Decision maker for all quality decisions at the site

Lead investigations into deviations, OOS/OOT results, complaints, and critical quality issues, ensuring timely CAPA implementation.

Oversee supplier and contractor qualification, audits, and quality agreements.

Ensure robust document control, data integrity, and training programs.

Compliance

Ensure site readiness for **regulatory inspections** (e.g., FDA, EMA) and customer audits.

Serve as the quality representative during inspections, audits, and regulatory engagements.

Ensure timely resolution of audit observations and implementation of preventive measures.

Monitor changes in global regulations and proactively adapt site quality systems to maintain compliance.

Leadership

Serve as the primary quality authority for the site, ensuring that all activities comply with cGMP, ICH, FDA, EMA, and other applicable regulatory standards.

Lead the implementation and continuous improvement of quality systems and procedures to ensure product quality, safety, and integrity.

Collaborate closely with Operations, Supply Chain, and other functions to ensure harmonized and efficient quality processes across the site.

Foster a strong **quality culture** **,** emphasizing right-first-time execution, accountability, and continuous improvement

Lead, mentor, and develop the QA and Quality Systems teams.

Ensure that all quality staff receive appropriate training to remain current with cGMP and regulatory requirements.

Create a high-performance team environment, promoting collaboration and continuous learning

Qualifications

Education & Experience

+ Bachelor's or advanced degree in Pharmacy, Chemistry, Microbiology, Engineering, or a related life science field

+ 15+ years' Quality Assurance / Compliance experience in pharmaceutical/ biotech industry, with at least five years in a senior leadership or site quality head role.

+ Deep expertise in **cGMP, FDA 21 CFR Parts 210/211, ICH Q10** **,** and other global regulatory standards.

+ Proven track record of successfully leading regulatory inspections and audits.

+ Strong experience with **quality systems** (CAPA, deviation, change control, risk management, etc.)

Knowledge

+ **Leadership & Vision:** Inspires and guides teams to achieve a culture of quality and excellence.

+ **Results Orientation:** Delivers high-quality results under tight deadlines.

+ **Change Management:** Navigates and leads teams through organizational and regulatory changes.

+ **Collaboration:** Builds effective cross-functional partnerships to achieve shared goals.

Skills & Abilities

+ Judgment - Displays willingness to make decisions; exhibits sound and accurate judgment; supports and explains reasoning for decisions; Includes appropriate people in decision-making process; makes timely decisions.

+ Quality Management - Looks for ways to improve and promote quality; demonstrates accuracy and thoroughness.

+ Motivation - Sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence; takes calculated risks to accomplish goals.

+ Planning/Organizing - Prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.

+ Professionalism - Approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.

+ Innovation - Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas; presents ideas and information in a manner that gets others' attention.

+ Project Management - Develops project plans; coordinates projects; communicates changes and progress; completes projects on time and budget; manages project team activities.

+ Ability to influence, peers and other colleagues without direct reporting lines.

+ Ability to look beyond own area of expertise and responsibility and to understand the overall business impact of actions taken.

+ Ability to work in a dynamic environment and constantly redefine the scope of responsibilities in alignment with compliance and business needs.

+ Excellent writing and communication skills.

+ Ability to multi-task and prioritize work.

+ Demonstrable computer skills.

Physical Requirements

+ Ability to travel domestically or internationally as business needs dictate.

**_Disclaimer:_** _The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required._

**EEO Statement:**

We firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.