Senior Director, GCP Quality
$217.6k - $326.4kVertex Pharmaceuticals
Vertex Pharmaceuticals seeks a Senior Director of GCP Operational Quality to lead strategic quality risk management and inspection readiness across clinical programs. This role provides oversight of quality strategies, lifecycle risk review, and cross-functional collaboration to ensure clinical quality outcomes and regulatory compliance.
Responsibilities
- Develop and oversee quality risk management strategies and inspection readiness plans across therapeutic programs
- Design program-specific quality strategies aligned with Global Clinical Operations, Medical Affairs, and Regulatory teams
- Lead implementation of risk-based approaches including Quality by Design and ongoing quality monitoring mechanisms
- Chair integrated GCP QA Operational Management Reviews to assess transparency, inspection readiness, and operational performance
- Partner with QA leadership on tools, metrics, and systems enabling accountability and operational performance management
Requirements
- Extensive global health regulatory agency knowledge across GCP and pharmacovigilance
- Demonstrated leadership in quality risk management and inspection readiness strategies
- Strong experience engaging clinical, medical, and cross-functional stakeholders
- Expertise in Quality by Design and risk-based quality management approaches
- Track record of developing and implementing quality management systems
- Experience with quality governance, audit oversight, and vendor management
Vacancy posted 25 days ago
Similar jobs that could be interesting for youBased on the Senior Director, GCP Quality in Boston, MA vacancy
$185k - $235k
OverviewMonte Rosa Therapeutics is seeking a Senior Director Quality GCP to provide strategic oversight of phase-appropriate Quality GCP and GCLP activities, including GCP quality oversight of ongoing quality activities supporting active pre-clinical and clinical programs...SeniorMonte Rosa Therapeutics
Boston, MA4 days ago$217.6k - $326.4k
Job DescriptionGeneral Summary:The Sr. Director, GCP Operational Quality will advance and provide strategic direction and oversight of the strategies, mechanisms, processes and capabilities for effective and proactive quality risk management across respective product/therapeutic...SeniorFull timeWork experience placementSummer workRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Boston, MA3 days ago$171.2k - $256.8k
...offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.SummaryThe Director, GCP & GLP QA, reporting to the Executive Director, Quality, is responsible for leading quality assurance oversight across clinical and nonclinical programs to...SeniorContract workTango Therapeutics
Boston, MA2 days ago- ...Tango Therapeutics seeks a Director of GCP & GLP Quality Assurance to oversee compliance across clinical trials and nonclinical laboratory operations in Boston. This role leads audit strategy, vendor management, regulatory inspections, and quality events while partnering...SeniorContract work
Tango Therapeutics
Boston, MA4 days ago - ...Type AnnuallyIndustry PharmaceuticalsSelling Points Drive clinical quality excellence in a hybrid executive role. Lead impactful audits and... ...Assurance team, ensuring adherence to Good Clinical Practices (GCP) and regulatory standards across clinical programs.Oversee...SeniorRemote work
Green Key Resources
Boston, MA3 days ago $185.6k - $232k
...benefits, see our website: The Importance of the Role The Director, Corporate Quality, will provide leadership and strategic quality oversight across... ...as a key Subject Matter Expert in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) compliance, ensuring...Full timeSarepta Therapeutics
Somerville, MA3 days ago$227.9k - $308.3k
Overview:The Senior Director, Global Pharmacovigilance Quality Assurance Lead provides executive leadership and independent quality oversight of Alnylam’s global... ..., and applicable ICH guidance; working knowledge of GCP interfaces is expected.Demonstrated success...SeniorFull timeTemporary workLocal areaRemote workFlexible hoursAlnylam Pharmaceuticals
Cambridge, MA21 hours ago$228k - $342k
Job DescriptionSenior Director, Quality Data, Digital Systems & ComplianceGxP Data Governance • Data... ...AnalyticsGeneral position summary:The Senior Director, Quality Data, Digital Systems... ...Operational/Quality experience (e.g., GMP, GCP, IT). Experience working across business...SeniorFull timeWork experience placementSummer workRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Boston, MA3 days ago- Akebia is seeking a RQA Director to lead day-to-day GCP/GLP/GVP Quality Operations. You will set strategic goals, manage budgets, hire and develop a QA team, and partner with internal and external stakeholders to protect study subjects and ensure compliance. The role reports...
- ...Senior Director role leading enterprise-wide GxP data governance, data integrity, master data management... ..., computerized systems compliance, and quality analytics. This strategic position... ...role in global organization ~ GMP, GCP, or IT operational/quality experience in...SeniorWork experience placement
Vertex Pharmaceuticals
Boston, MA4 days ago $210k - $290k
The Role: The Senior Director, GMP Quality will build/support and maintain fit-for-purpose quality systems, provide independent quality oversight of contract development and manufacturing organizations (CDMOs), contract testing laboratories, and other strategic partners...SeniorContract workFor contractorsShift workGenerate Biomedicines
Somerville, MA1 day ago$250k - $273k
...improving the lives of patients who need it most.We're seeking a Senior Director, Quality Compliance reporting to the VP, Head of Quality, who will be... ...industry.Demonstrated leadership experience in GMP, GCP, and/or GLP environments across development and commercial stages...SeniorWork at officeKiniksa Pharmaceuticals
Lexington, MA4 days ago$216k - $324k
Job DescriptionVertex is seeking a Senior Director, Head of Quality Control to lead QC strategy and external laboratory oversight for our Type 1 Diabetes Cell Therapy external manufacturing network. This leader will be responsible for building and scaling a robust QC partnership...SeniorFull timeContract workSummer workRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Boston, MA3 days ago$137k - $215.27k
...knowledge.Job DescriptionOBJECTIVES:Provides quality assurance oversight of the global... ...sites. ACCOUNTABILITIES:Provide expertise in GCP compliance interpretation, consultation,... ...problems and recommend appropriate solutions to senior management for immediate and long-term...SeniorMinimum wageWork at officeLocal areaImmediate startNight shiftTakeda
Boston, MA4 days ago- Scorpion Therapeutics seeks an Associate Director, Clinical QA to provide hands-on quality oversight of biopharma's clinical and nonclinical programs to ensure compliance with GCP, GLP, and GCLP standards. This role leads audits of CROs, laboratories, and investigator...Senior
$210k - $300k
...willingness to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview As the Senior Director, Analytical Development and Quality Control , you will provide strategic and technical leadership for analytical development and quality control...SeniorFull timeContract workWork at officeRhythm Pharmaceuticals
Boston, MAmore than 2 months ago$137.8k - $206.8k
Job DescriptionGeneral Summary:The Senior Manager, Clinical Study Quality Lead provides study-level quality oversight for assigned clinical trials to help... ...conducted in compliance with Good Clinical Practice (GCP), applicable global regulations, study protocols, and Vertex...SeniorFull timeSummer workRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Boston, MA4 days ago$185.6k - $232k
...Sarepta Therapeutics seeks a Director of Corporate Quality to provide strategic quality oversight across clinical development and real-world evidence programs. This role ensures GCP and GLP compliance across clinical trials and non-clinical studies, serving as a subject...- ...is a member of the GVP QA team providing Quality oversight of the global post-marketing pharmacovigilance... ...activities.This position reports to the Director, Global PV Quality Assurance and... ..., EA).Summary of Key Responsibilities: Senior Manager, PV QA supports all the GVP QA’s...SeniorWork experience placementRemote workWorldwide
Planet Pharma
Somerville, MA21 hours ago $107.64k - $217.81k
...areas of inspiration and expand your capabilities, then consider a career in Advisory.KPMG is currently seeking a Sr. Associate, Cloud - GCP for our Consulting practice.Responsibilities:Lead the design and implementation of Google Cloud Platform (GCP) infrastructure using...SeniorH1bLocal areaKPMG
Boston, MA2 days ago$240k - $285k
...improvement for individuals, families and communities. Learn more at , and follow us on X, LinkedIn and Facebook.Role Summary:The Senior Director, Quality Control leads the strategy and execution of Quality Control activities that support clinical and commercial manufacturing,...SeniorContract workLocal areaDyne Therapeutics
Waltham, MA1 day ago$135k - $205k
Position Summary As a Senior GCP Architect (Lead Cloud Infrastructure Engineer II) at Deloitte, you will lead the architecture and... ...verbal communication skillsMeticulous attention to detail and quality of work productAbility to build and sustain professional...SeniorLocal areaRemote workDeloitte
Boston, MA2 days ago- ...Senior Quality Manager We are currently seeking a Senior Quality Manager for our work in Winthrop, MA. The Senior Quality Manager is responsible for implementation, improvement and execution of the Quality management systems (QMS) and project specific quality program...SeniorContract workWork experience placementFor subcontractor
The Walsh Group
Winthrop, MA3 days ago - ...Madrigal is seeking an experienced Senior Director, Product Quality Lead (Post-Marketing and Pharmacovigilance Quality) to guide and mature the global PV Quality function during a critical growth phase. You will oversee post-marketing safety surveillance, literature monitoring...Senior
- ...Senior Director of GMP Quality will establish and maintain quality systems, provide oversight of manufacturing partners and testing laboratories, and ensure regulatory compliance. This hands-on leadership role partners with cross-functional teams from development through...SeniorContract work
- Take the lead in shaping global pharmacovigilance quality excellence, overseeing critical audit programmes, vendor quality, and regulatory compliance activities. R&D Partners is seeking a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to provide quality...Senior
- Proclinical seeks a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to lead quality oversight of global PV systems from Cambridge, MA, with... ...across international teams.The role reports to the Director of Global PV Quality Assurance and focuses on GVP compliance...SeniorRemote job
$216k - $324k
...Vertex Pharmaceuticals seeks a Senior Director to lead quality control strategy and external laboratory oversight for Type 1 Diabetes cell therapy manufacturing. The role focuses on building and scaling a QC partnership model across contract manufacturers and testing laboratories...SeniorContract work$138k - $190k
Job Description The Senior Manager, Clinical Quality Assurance is responsible for the development, maintenance and oversight of GCP activities related to the Clinical Trial activities sponsored by Deciphera. The primary responsibilities are to ensure both quality and compliance...SeniorContract work$226.1k - $339.1k
Job DescriptionGeneral Summary:The Senior Director, Analytical Development is a senior leadership role within the Cell and Gene Therapy Analytical... ...closely with Manufacturing, Process Development, Regulatory, Quality, CMC, and external partners to generate high-quality data...SeniorFull timeSummer workFlexible hoursVertex Pharmaceuticals
Boston, MA3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Director, GCP Quality. Be the first to apply!
Related searches
- director supplier quality Boston, MA
- training and quality manager Boston, MA
- global quality manager Boston, MA
- director of quality & patient safety Boston, MA
- quality manager Boston, MA
- director quality assurance regulatory affairs Boston, MA
- director of quality improvement Boston, MA
- director of quality Boston, MA
- quality manager healthcare Boston, MA
- corporate quality manager Boston, MA