6,934 Clinical Qa jobs in the United States

• Lead Biopharma Qualification and Routine Audits, as requested.
• Support external audits performed by regulatory/inspections agencies.
• Facilitate audit/inspection readiness training and activities.
• Track and manage pre-audit deliverables to ensure timely fulfillment.
• Support the communication of audit observations/recommendations
• Support the preparation of audit responses.
• Support the compilation of audit metrics.
• Assist in the internal GCP activities, such as internal audits.
• Contributes to the development of controlled documentation, as needed.
• Travel domestically up to 10% of the time.
• Support other QA duties as assigned.

• Bachelor's Degree in a science or engineering discipline and 5+ years of experience in the medical device, diagnostics, or biopharmaceutical industry with direct involvement in clinical trials; OR
• Master's Degree in a science or engineering discipline with 3+ years of experience

• Experience or familiarity with Medical Devices
• Knowledge of Good Clinical Practice (GCP)
• Demonstrated ability to maintain accurate audit records
• Knowledge of Microsoft Office applications (e.g. Word, Excel, Powerpoint)
• Knowledge of root cause analysis and corrective and preventative action
• Ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements
• Ability to effectively communicate verbally and in writing within the team and with other functional teams
• Ability to cooperate and collaborate effectively with a team
• Highly detail oriented
• Excellent time management skills and ability to deliver requested tasks on time
• Understanding of HIPAA and importance of privacy of patient data
• Commitment to FMI values: patients, innovation, collaboration, and passion.

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About The Job

The Senior Clinical QA Lead plays a key role as the Audit Lead in Biopharma Qualification Audits and select Partner Routine Audits. The Audit Lead is responsible for the successful execution of the audit including audit prep activities such as the pre-audit call facilitator, Internal Audit Prep Meeting Lead, and the Audit itself. Audit Leads act as a Point of Contact during the audit for internal stakeholders ensuring audit objectives are met.

About The Job

The Senior Clinical QA Lead plays a key role as the Audit Lead in Biopharma Qualification Audits and select Partner Routine Audits. The Audit Lead is responsible for the successful execution of the audit including audit prep activities such as the pre-audit call facilitator, Internal Audit Prep Meeting Lead, and the Audit itself. Audit Leads act as a Point of Contact during the audit for internal stakeholders ensuring audit objectives are met.

This position works collaboratively with groups throughout the organization to ensure compliance with regulatory requirements and support a diverse array of projects and initiatives. The Clinical QA Lead contributes to QA activities across multiple quality system requirements (CLIA/CAP, GCP, ISO and FDA regulated environments).

Key Responsibilities

• Lead Biopharma Qualification and Routine Audits, as requested.
• Support external audits performed by regulatory/inspections agencies.
• Facilitate audit/inspection readiness training and activities.
• Track and manage pre-audit deliverables to ensure timely fulfillment.
• Support the communication of audit observations/recommendations
• Support the preparation of audit responses.
• Support the compilation of audit metrics.
• Assist in the internal GCP activities, such as internal audits.
• Contributes to the development of controlled documentation, as needed.
• Travel domestically up to 10% of the time.
• Support other QA duties as assigned.
  
  

• Bachelors Degree in a science or engineering discipline and 5+ years of experience in the medical device, diagnostics, or biopharmaceutical industry with direct involvement in clinical trials; OR
• Masters Degree in a science or engineering discipline with 3+ years of experience
  
  

• Experience or familiarity with Medical Devices
• Knowledge of Good Clinical Practice (GCP)
• Demonstrated ability to maintain accurate audit records
• Knowledge of Microsoft Office applications (e.g. Word, Excel, Powerpoint)
• Knowledge of root cause analysis and corrective and preventative action
• Ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements
• Ability to effectively communicate verbally and in writing within the team and with other functional teams
• Ability to cooperate and collaborate effectively with a team
• Highly detail oriented
• Excellent time management skills and ability to deliver requested tasks on time
• Understanding of HIPAA and importance of privacy of patient data
• Commitment to FMI values: patients, innovation, collaboration, and passion.
  
  

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Health Care Provider

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• Lead Biopharma Qualification and Routine Audits, as requested.
• Support external audits performed by regulatory/inspections agencies.
• Facilitate audit/inspection readiness training and activities.
• Track and manage pre-audit deliverables to ensure timely fulfillment.
• Support the communication of audit observations/recommendations
• Support the preparation of audit responses.
• Support the compilation of audit metrics.
• Assist in the internal GCP activities, such as internal audits.
• Contributes to the development of controlled documentation, as needed.
• Travel domestically up to 10% of the time.
• Support other QA duties as assigned.

• Bachelor's Degree in a science or engineering discipline and 5+ years of experience in the medical device, diagnostics, or biopharmaceutical industry with direct involvement in clinical trials; OR
• Master's Degree in a science or engineering discipline with 3+ years of experience

• Experience or familiarity with Medical Devices
• Knowledge of Good Clinical Practice (GCP)
• Demonstrated ability to maintain accurate audit records
• Knowledge of Microsoft Office applications (e.g. Word, Excel, Powerpoint)
• Knowledge of root cause analysis and corrective and preventative action
• Ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements
• Ability to effectively communicate verbally and in writing within the team and with other functional teams
• Ability to cooperate and collaborate effectively with a team
• Highly detail oriented
• Excellent time management skills and ability to deliver requested tasks on time
• Understanding of HIPAA and importance of privacy of patient data
• Commitment to FMI values: patients, innovation, collaboration, and passion.

Job Description

The Clinical Trials QA Director is responsible for setting the strategic vision for the global Clinical Quality function, aligning it with corporate objectives, risk tolerance, and evolving regulatory expectations. Acts as primary QA liaison to executive leadership, regulatory agencies, and external partners for clinical quality matters. Also, assures compliance of clinical development program with Good Clinical Practice (GCP), regulatory requirements (e.g., FDA, EMA, MHRA, ICH E6(R2)), and company SOPs. The role provides quality oversight of clinical trial operations, audits, ongoing CRO qualification and management, and inspection readiness, working closely with Clinical Operations, and CROs.

Some relocation may be available for this role.

Duties and Responsibilities (Responsibilities include but are not limited to):

• Direct the design, implementation, and continuous improvement of the Clinical Quality Management System (CQMS) across all global clinical programs.
• Establish corporate GCP quality objectives, KPIs, and risk indicators; report to the executive team and board committees on quality performance and compliance trends.
• Oversee and approve the global GCP audit program, including strategic vendor qualification, investigator oversight, and emerging market entry readiness.
• Serve as the company’s lead representative for regulatory inspections globally, shaping inspection strategy, responses, and CAPA governance at the enterprise level.
• Chair cross‑functional quality governance forums to ensure alignment across Clinical Operations, Regulatory Affairs, Pharmacovigilance, and Manufacturing QA.
• Sponsor initiatives for digital quality systems (eQMS, eTMF) optimization, leveraging data analytics for proactive compliance monitoring.
• Influence CRO/vendor quality expectations via contractual quality agreements and executive governance meetings.
• Shape company policy in response to new ICH guidelines and emerging GCP interpretations; lead global implementation strategies.

• Provide leadership and direction to a team of QA personnel, and Auditors.
• Mentor QA talent and succession plan for critical quality roles.
• Hold budgetary and resource allocation responsibility for the Clinical QA function.

• Bachelor’s required, advanced degree preferred (MS, PharmD, PhD, or MPH) in life sciences or related discipline.
• 8+ years of progressive QA experience in clinical environment, with a minimum of 5 years in a leadership role (multi‑site, multi‑region trials).
• Proven track record of leading global regulatory inspections and shaping corporate quality strategy across multiple health authority jurisdictions.
• Demonstrated ability to influence at the executive and board level.

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Job DescriptionJob Description

ABOUT US AT KINDER'S:

We are a fast-growing company working hard to bring amazing flavor solutions to consumers that are as exciting and delicious as they are simple to use. Whether we are serving the emerging cook or seasoned pro, we are 100% committed to our mission of bringing awesome flavor to consumers wherever and whenever they are looking for it and in whatever form they want it in be it seasonings, sauces, gravies, marinades, or anything else we can dream up. We drive hard to be the most quality-obsessed, innovative company in any market we serve and while we have experienced tremendous growth over the last 5 years, we think we are just getting started. We love our consumers and are fired up to be part of their flavor journey, and we need more great people to help us continue to raise the bar for what consumers think is even possible in their own kitchens.

Today, we have over 100 products sold nationwide at retailers including Costco, Walmart, Sam's Club, Whole Foods, Sprouts, Kroger, Safeway and many more. While we have been around for over 75 years, we have experienced explosive growth in the last 5 years and are now a top 5 brand in the U.S. in multiple flavor categories including seasoning blends, BBQ sauce, and wing sauce. To keep our momentum rolling, we need more passionate flavor advocates and builders to come and join our team and help us reach every kitchen across the U.S. and maybe even the world.

How you'll have an impact at Kinder's: The Regulatory Compliance Manager will be part of a team responsible for ensuring that Kinder's packaging meet all regulatory guidelines. You will play a critical role in both defining and driving regulatory compliance with our high quality standards. You will partner with Kinder's leaders, cross-functional teams and external resources to ensure Kinder's delivers high quality and amazing tasting products consistently while adhering to industry best practices for food safety and quality assurance.

What are the Key Responsibilities of this Role

• Develop "best in class" regulatory labelling methodology and systems ensuring compliance for all packaging materials with applicable third parties and regulatory agencies.
• Interact and problem solve with external quality, regulatory bodies and consultants to ensure that Kinder's packaging meet all applicable requirements.
• Ensure that all labels and documentation are compliant with regulatory requirements and are accurate based on product formulations, ingredients etc.
• Monitor regulatory activities with food labelling regulatory standards and act as a liaison for all labelling regulatory compliance within Kinder's.
• Thoroughly review and approve all labeling materials, including nutrition facts panels, ingredient lists, allergen statements, and other text on packaging.
• Ensure labels comply with relevant regulations from agencies i.e. FDA, USDA and other certifying bodies.
• Verify that labels are accurate and truthful.
• Stay up-to-date on current and proposed food regulations.
• Develo and manage certification programs such as USDA Organic, COR, Gluten Free, or Kosher.
• Monitor and research industry trends, competitive products, and consumer advocacy groups.
• Interpret and apply regulations to specific product types and labeling situations.
• Maintain and update databases containing product specifications, nutritional information, ingredient lists, and allergen declarations.
• Utilize software and systems for managing and tracking labeling information.
• Prepare and maintain label transmittals and other documentation for regulatory submissions.
• Ensure all labeling-related documentation is accurate and readily available.
• Work with cross-functional teams, including R&D, marketing, and manufacturing, to ensure compliance throughout the product lifecycle.
• Provide guidance, training and support to other departments on labeling requirements.
• Develop and implement labeling strategies to align regulatory requirements with the business speed to market commitments.
• Review and approve advertising materials and other consumer-facing content.
• Ensure that imported and exported products comply with each market's labeling requirements.
• May be involved in product development to ensure compliance is considered from the outset.
• Other responsibilities may be included as required by the business or leadership.

What You Bring to the Table

• Bachelor's Degree required. Preference for degree in food science, nutrition or related field.
• 5-10 years relevant experience in food labeling or regulatory compliance in the food industry.
• Excellent understanding of FDA, CFIA and USDA food labeling regulations.
• Familiarity with nutrition labeling software.
• Experience with label submission and approval systems.
• Ability to interpret and evaluate product packaging, nutrition facts panels, ingredient and allergen statements.
• Ability to communicate effectively with cross-functional teams and stakeholders.
• Ability to manage multiple tasks and deadlines.
• Accuracy and thoroughness.
• Experience in CPG product development or food manufacturing is .
• Experience being part of an organization driving rapid innovation, product launches and product development is .
• Collaborative business partner with a track record of helping internal and external stakeholders identify win-win solutions and driving alignment around best course of action and accountability for delivering committed outcomes.
• Strong analytical & problem solving skills with ability to collect and use quantitative data to drive more effective decision-making.

Personal Characteristics

• Business builder who owns and drives results and motivation, teambuilding, collaboration.
• Growth mindset with an excitement to learn and teach.
• Thrive in a dynamic, lean, and agile environment with proven record of completing projects on time in full through excellent cross functional team management, leadership, communication and influence.
• A self-starter and decisive leader who is not afraid to make tough calls, challenge assumptions, and drive alignment across cross-functional teams.
• Takes accountability for results and embraces Kinder's fast-moving, high-impact culture.
• Excited to be part of a fast-moving team with the ability to be a leader, team member and a follower.
• Enjoys making decisions & finding ways to say 'yes' as often as possible to impactful priorities.
• Strong ability to prioritize key issues based on business risk and needs of organization.

Things About the Way We Work

• No two days here are the same.
• We try to be good team members and good communicators, but we don't live by hierarchy and structure everyone is a difference maker here.
• We make a lot of decisions in the face of incomplete information our team embraces.
• ambiguity and tries to make good decisions fast rather than great decisions slow.
• We encourage leaders to take smart, calculated risks that balance innovation with business impact. We operate with a bias toward action and a results-driven mindset, ensuring we make decisions fast and adapt as needed. Our leaders empower their teams and foster a collaborative, transparent environment.
• We believe in growing our skills and becoming a better company with more managerial.
• expertise, but we are an entrepreneurial company at heart.
• We aren't trying to be average we want to do exceptional things and we are willing to work hard to achieve them.

Location & Travel

The position will be based out of our 40,000 sq. foot office in Walnut Creek, CA. We strongly believe in the power of culture and community and have a hybrid work structure with 4 days in the office on a weekly basis to encourage collaboration and personal connections that will allow us to better serve our customers and consumer and to have more fun. We have 1 flex day per week with employees having the opportunity to choose to be either in the office or to work from home based on what makes most sense for them.

The expected starting salary range for this role is $130,000- $145,000 per year. We may ultimately pay more or less than the posted range based on the location of the role. The amount a particular employee will earn within the salary range will be based on factors such as relevant education, qualifications, performance and business needs.

Regulatory Compliance. Provide subject matter expertise on federal, state, and local regulatory requirements (e.g., CMS compliance, Stark and Anti-Kickback laws, physician compensation). Provide expert compliance guidance to leadership, staff, and st Compliance Director, Regulatory, Compliance, Director, Leadership, Healthcare, Business Services