Director, GCP/GLP/GVP Quality Assurance
Bienvivir All Inclusive Health
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 to CTO/SVP of Quality and sits on the Quality Leadership Team, overseeing QA processes from first-in-human to commercial authorization in a fast-growing environment. #J-18808-Ljbffr Bienvivir All Inclusive Health
$171.2k - $256.8k
...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 ensure compliance with...SuggestedContract work- ...Vor Biopharma seeks a Director to lead global Clinical and Pharmacovigilance inspection... ...clinical operations, pharmacovigilance, and quality functions to ensure sustained inspection... ...and continuous improvement of global GCP/GVP inspection readiness program Serve as...Suggested
$160k - $195k
...us on X, LinkedIn and Facebook.Role Summary:The Associate Director, Quality Management Systems is a key member of the quality team responsible... ...pharmaceutical environments, with exposure across GxPs (GCP, GLP, GMP, GVP preferred) Demonstrated experience with direct ownership...SuggestedLocal area- Role: Associate Director, Clinical QA, providing hands-on quality oversight of biopharma's clinical and nonclinical programs to ensure compliance with GCP, GLP, and GCLP standards. Responsibilities: lead audits of CROs, laboratories, and investigator sites domestically...Suggested
$190k - $220k
Position Summary: The Associate Director, Clinical QA will provide hands‑on quality oversight of Korro Bio's... ...with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Clinical... ...in GCP or clinical Quality Assurance, with a track record of independently...SuggestedContract work$159.94k - $197.57k
...Associate Director, Research Quality Assurance Waltham, Massachusetts, United States Nearly... ...leadership in Good Clinical Practice (GCP), Good Pharmacoepidemiology... ...), Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP) and applicable regulations...Contract workFor contractorsWork at officeRelocationFlexible hours$156.6k - $234.8k
...Associate Director, GMP Operational Quality The Associate Director, GMP Operational Quality is responsible... ...and application of quality assurance and compliance. The incumbent is responsible... ...assigned clinical programs providing GCP compliance interpretation, consultation...Work experience placementSummer workRemote workFlexible hoursDay shift2 days per week- Korro Bio is seeking an Associate Director, Clinical QA to oversee quality across clinical and nonclinical programs, ensuring GCP/GLP/GCLP compliance. The role emphasizes auditing CROs, labs, and sites in the US and abroad, with practical risk-based judgment to protect...
$110k - $170k
Position Summary As a GCP Technical Account Manager (Cloud Infrastructure Engineer III), you will support Public Sector customers... ...verbal communication skillsMeticulous attention to detail and quality of work productAbility to build and sustain professional...Local areaRemote work$195k - $218k
...care. Role: Century Therapeutics is seeking a Director of Translational Sciences to serve as a senior... ...purpose, scientifically rigorous, and compliant with GCP/GLP expectations for clinical trials. • Set quality and scientific standards for assay development...Local area$160.6k - $240.8k
...DescriptionGeneral Summary:The Clinical Study Quality Lead (SQL), Associate Director is responsible for advanced quality assurance oversight of clinical trial operations and... ...clinical trials are conducted in accordance with GCP requirements, applicable protocols, Vertex...Full timeWork experience placementSummer workWork at officeRemote workFlexible hours2 days per week$185k - $225k
...vision of providing life-long cures to patients suffering from serious diseases.Position Overview:We are seeking an Associate Director, Quality Control to lead the Beam Massachusetts Quality Control team in delivering compliant, scientifically sound, and timely GMP testing...Full time$135.46k - $203.19k
Job Title: Associate Director, External QualityLocation: Boston, MA Hybrid 3 days/weekFusion Pharmaceuticals, a member of the AstraZeneca... ...demand for our growing pipeline of RCs.The Role:AD, External Quality - Radio Conjugates is accountable for end-to-end Quality oversight...Full timeContract workTemporary work$184.6k - $277k
Job DescriptionGeneral/Position SummaryThe Director, Manufacturing Process & Technical Quality provides Quality leadership and end-to-end technical Quality oversight for assigned Cell & Genetic Therapies programs from development through commercialization and post-approval...Full timeSummer workRemote workFlexible hours2 days per week$185k - $225k
...and a vision of providing life-long cures to patients suffering from serious diseases.Position Overview:The Associate Director of Product Quality Assurance (PQA) will be responsible for phase appropriate quality oversight of internal and external manufacturing and...Full timeContract workWorldwide$147.5k - $221.3k
Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness and compliance of external sites including evaluating, improving, and monitoring commercial level quality compliance and quality...Full timeSummer workRemote workFlexible hours2 days per week$156.6k - $234.8k
...DescriptionGeneral Summary:The Manufacturing Process & Technical Quality Associate Director provides end-to-end l quality oversight for cell and gene... ...:Process Lifecycle ManagementServe as a Quality Assurance Subject Matter Expert (SME) for product and process lifecycle...Full timeContract workSummer workRemote workFlexible hours2 days per week$158.8k - $238.2k
...DescriptionGeneral Summary:The Associate Director, QC Technical Services - Small Molecule... ...also includes operational oversight of quality event management, stability execution, regulatory... ..., Program Management, and Quality Assurance to support commercial small molecule...Full timeContract workSummer workRemote workFlexible hours2 days per week$172k - $202k
...Addition to Our TeamYou are motivated, resourceful, and enthusiastic quality control lead excited to be a key contributor for the company at... ...groups, including, non-clinical development, quality Assurance, Regulatory, and CRO/CDMOs. Your ability and desire to thrive in...Work at officeLocal areaRemote work1 day per week$252k - $378k
...DescriptionGeneral Summary:The Medical Affairs Senior Director provides medical and scientific... ...company policies, medical affairs SOPs, GCP and ICHAssesses promotional materials and... ...allotted time frames & delivering high-quality successful resultsAbility to engage in positive...Full timeSummer workRemote workFlexible hours2 days per week$206k - $257.5k
...functional teams to ensure scientifically rigorous study designs, high-quality analyses, and successful execution of statistical deliverables.... ..., and regulatory submission materials.Strong understanding of GCP and applicable statistical and regulatory guidance.Excellent...Full timeInterim role- ...Associate Director role overseeing clinical trial quality assurance and GCP compliance across assigned disease areas. The position involves developing audit and inspection strategies, managing quality risks, investigating compliance issues, and serving as a technical expert...Work at office
$210k - $260k
...for products in the Beam portfolio. The Director of Pharmacovigilance will contribute to a... ...Affairs, Medical Writing, Nonclinical, and Quality.Responsibilities:Oversight of day-to-day... ...regulations including but not limited to FDA, EU, GVP, ICH guidelines and regulations...Full time3 days per week1 day per week$323k
Overview:The Senior Director, Pathology will provide scientific leadership for the interpretation... ...platform and program supportReview non-GLP and GLP study clinical pathology... ...collaborate with all pathology team members to assure optimal support of data generation and...Full timeTemporary workLocal areaFlexible hours$252k - $378k
Job DescriptionGeneral Summary:The Senior Director (non-MD) serves as a US Medical Affairs asset lead responsible for the strategic planning... ...full compliance with Vertex policies, US laws and regulations, GCP, ICH guidelines, and applicable codes of practice.Required...Full timeSummer workRemote workFlexible hoursShift work2 days per week$153.9k - $230.9k
Job DescriptionGeneral/Position SummaryThe Associate Director - Shift Quality Operationsis an advanced technical resource in the principles and application of quality assurance and compliance. The Associate Director provides quality leadership and oversight for manufacturing...Full timeSummer workFlexible hoursShift work$229.61k - $295.18k
...The Director of Pharmacovigilance (PV) will provide strategic and operational support... ...Affairs, Data Management, Biostatistics, Quality Assurance, and external pharmacovigilance vendors... ...and Good Pharmacovigilance Practices (GVP). Contribute to ongoing safety surveillance...$258.33k - $280k
...This is a highly visible, unique opportunity for a seasoned quality systems professional who thrives in fast-paced, resourceful... ...technical field. • 10+ years of experiencein biotech/pharma Quality Assurance, with direct ownership of GxP systems and a proven track...Remote work3 days per week- ...Vertex is seeking an Associate Director, CMC Quality Compliance and Inspection Readiness to lead inspection readiness programs across external sites, drive continuous improvement, and partner across functions to sustain regulatory compliance and a strong quality culture...
$155k - $214k
About This Role:As the Associate Director, Global Quality Risk Management, you will be at the forefront of Biogen’s commitment to quality excellence. Leading the charge in designing, implementing, and sustaining the enterprise Quality Risk Management (QRM) capabilities...Full timeTemporary workLocal area
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