GCP & GLP QA Lead — Clinical & Nonclinical
Tango Therapeutics
Tango Therapeutics, a Boston-based biotechnology company, seeks a Director, GCP & GLP QA to lead quality assurance across clinical and nonclinical programs, ensuring compliance with GCP, GLP, and global regulatory standards. You will oversee audits, inspections, vendor quality management, and CAPA programs while partnering with internal teams and external partners. You will drive qualification activities for CROs and labs, support regulatory submissions, and guide QA strategy to sustain quality #J-18808-Ljbffr Tango Therapeutics
$171.2k - $256.8k
...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 GCP, GLP, and global...SuggestedContract work- ...Prilenia Therapeutics, a clinical‑stage biotechnology... ...and their families. Our lead product candidate, pridopidine... ...The Director/Sr. Dir, GCP Quality Assurance is Prilenia... ...and serving as sponsor QA counterpart to our CRO(s... ...(GVP) and pre‑clinical (GLP) activities. The ideal...SuggestedFull timeRemote workFlexible hours
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- Wave Life Sciences is seeking a Senior IT Business Analyst, located in Lexington, MA, to support GLP/GMP systems. This role focuses on business analysis and IT systems for quality assurance and regulatory affairs, ensuring compliance and data integrity within a GxP environment...Suggested
$185k - $235k
...seeking a Director Quality GCP to provide strategic... ...activities supporting active pre-clinical and clinical programs... ...and remediated.Provide QA GCP review and feedback... ...regulatory submissions. Lead and participate in... ...EMA, ICH, MHRA, etc.). GLP experience a plus.Able to...$252k - $269k
...Clinical Quality Assurance Senior Leader provides strategic leadership... ...oversight of Alkermes GLP/GCP/GVP quality programs to ensure... ...requires an experienced Clinical QA Senior leader who can build high... ...program objectives. Develop and lead Risk Management assessments with...Local areaWorldwide- Vertex Pharmaceuticals is seeking a Senior Manager, Clinical Study Quality Lead to provide study-level quality oversight for assigned clinical trials, ensuring GCP compliance with global regulations, study protocols, and Vertex procedures. The role partners with clinical...
$136k - $170k
.... Manager, Corporate Quality - GCP, will provide program-level quality... ...support across Sarepta’s Clinical Development and Real-World Evidence... ...and deliver proactive QA guidance throughout the trial lifecycle... ...in Clinical and QA operations. Lead integration of acquired...Full time$185.5k - $344.5k
...overseeing.Job DescriptionKey Responsibilities: Lead and provide strategic oversight to the... ...ensuring SEND (Standard for Exchange of Nonclinical data) datasets are of high-quality and... ...and de novo generation for internal non-GLP studiesOversight of SOPs and training records...Full time- A biopharmaceutical company in Boston is seeking a Senior Director for GCP Quality Oversight. This pivotal role involves managing GCP activities for clinical trials, ensuring compliance with regulations and best practices. Candidates must possess a Bachelor's degree and...Work at officeFlexible hours
- ...motivated Senior Director, Head of Clinical Quality Assurance to provide... ...for Good Clinical Practice (GCP) quality across the company’s biologics... ...serve as the senior Clinical QA leader and trusted partner to... ...Position Responsibilities: Lead the Clinical Quality Assurance...
- ...Executive Director of Clinical Quality About the Company Pharmaceutical company focused... ...Executive Director of Clinical Quality to lead its Clinical Quality Assurance team. The successful... ...adherence to Good Clinical Practices (GCP) and regulatory standards across clinical...
$168.1k - $268.7k
...As Director, Clinical Quality Assurance Compliance you will lead quality assurance activities across clinical development programs in global teams. This... ...implementing a proactive, risk-based quality strategy, ensuring GCP compliance, fostering a culture of quality within the...$138k - $190k
...Description The Senior Manager, Clinical Quality Assurance is... ..., maintenance and oversight of GCP activities related to the Clinical... ...Draft, review or revise Clinical QA SOPs to assess consistency and... ...understanding and application of GCP, GLP and ICH requirements,...Contract work$185.5k - $344.5k
...overseen by the group. Key Responsibilities Lead and provide strategic oversight to the... .... Ensure SEND (Standard for Exchange of Nonclinical Data) datasets are of high quality and... ...and de‑novo generation for internal non‑GLP studies. Oversee SOPs and training records...- EPM Scientific is partnering with a clinical-stage biotechnology company to hire a Senior Quality Assurance Document Specialist. The role focuses on document control, training management, and quality system processes to support readiness for commercialization. Responsibilities...
$164.5k - $222.5k
..., Early Development Quality Lead, R&D QAOverview The Early Development... ...) activities in support of nonclinical studies (GLP and non-GLP), IND enabling... ...programs (preclinical and clinical).This role will partner with... ...teams (in partnership with GCP Program Leads) to integrate...Full timeTemporary workWork experience placementLocal areaRemote workFlexible hours- ...management, to the system's back and front end architecture.You would be responsible for:Creating test plans and guiding a small offshore QA team.Writing, maintaining and hands-on executing manual and automated test suitesReviewing functional requirements, design documents,...
- ...YO IT Consulting is seeking a Mathematics Quality Assurance Lead. This remote contractor role encompasses overseeing quality across mathematics AI training projects. You will review AI-generated math content, assess work for accuracy, and communicate feedback to ensure...For contractorsRemote work
$90k - $115k
...team that wants to lead with the desire to... ...Our client is in the clinic with their lead CAR... ...with business and QA stakeholders to embed... ...Clinical Practice (GCP) standards for... ...regulatory inspections (GLP, GCP, GVP and other... ..., ensuring both nonclinical and clinical teams...Work experience placementRemote workWorldwideShift work- ...quality metrics and governance, and plans/leads risk‑based audits with durable CAPA... .../or oversee risk‑based vendor audits (GCP/GLP/GCLP as applicable); plan, conduct,... ...environment. Preferred: vendor oversight across clinical and nonclinical domains (e.g., CROs, central/specialty...Work from home
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$137.8k - $206.8k
...DescriptionGeneral Summary:The Senior Manager, Clinical Study Quality Lead provides study-level quality oversight... ...with Good Clinical Practice (GCP), applicable global regulations, study... ...candidate brings direct, hands-on GCP QA experience supporting clinical trials in...Full timeSummer workRemote workFlexible hours2 days per week- United States Digital Space LLC in Boston, MA is seeking a Firmware QA Engineering Manager to lead the Hardware Accelerate team, building the technology foundation for quality firmware development. The role blends technical leadership with people management to deliver...
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$153.6k - $241.34k
Associate Director, Clinical & Quality Process Compliance Location: Cambridge, MA - Hybrid... ..., with at least 3 years of experience in GCP Quality/Compliance. Advanced knowledge of... ...pharmacovigilance audit program, hosting or leading regulatory inspections, investigations,...Temporary workLocal areaRelocation package- A leading global pharmaceutical company is seeking an Associate Director for Clinical & Quality Process Compliance. This role involves ensuring high-quality standards across... ...industry, particularly in Clinical Operations and GCP Quality. Responsibilities include managing...
- A leading healthcare solutions provider is seeking an Associate Director, Clinical Program Quality Leader in Cambridge, MA. The candidate will provide quality assurance oversight... ...programs, ensuring inspection readiness and GCP compliance. A minimum of 10 years in the...Hourly pay
$160.6k - $240.8k
Job DescriptionGeneral Summary:The Clinical Study Quality Lead (SQL), Associate Director is responsible for advanced quality assurance oversight of... ...ensure clinical trials are conducted in accordance with GCP requirements, applicable protocols, Vertex policies and procedures...Full timeWork experience placementSummer workWork at officeRemote workFlexible hours2 days per week
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