Senior Director, GCP Quality & Compliance
Remix Therapeutics
Remix Therapeutics, a clinical-stage biopharmaceutical company pioneering RNA splicing therapies, seeks a GCP Quality Assurance leader in Watertown, MA. You will oversee GCP activities across sponsored trials, ensuring SOP alignment with US FDA, ICH, GLP and ICH E6 standards, while guiding Clinical Operations and QA teams. You will drive risk-based quality programs, coordinate CAPAs, support drug safety reviews, and participate in internal and external audits.
#J-18808-Ljbffr$230k - $281k
...patients deserve. Position Summary: The GCP Quality Assurance candidate will manage... ...responsibilities will be to ensure both quality and compliance of company sponsored clinical trials... .../or lack of urgency in remediation to senior management. Perform program specific...SeniorContract work$217.6k - $326.4k
Job DescriptionGeneral Summary:The Sr. Director, GCP Operational Quality will advance and provide strategic direction and oversight of the strategies... ..., proactive and sustainable clinical quality, and compliance for assigned programs. This individual will integrate end...SeniorFull timeWork experience placementSummer workRemote workFlexible hours2 days per week$171.2k - $256.8k
...Fenway area of Boston, Massachusetts.SummaryThe Director, GCP & GLP QA, reporting to the Executive Director, Quality, is responsible for leading quality assurance... ...across clinical and nonclinical programs to ensure compliance with GCP, GLP, and global regulatory...SeniorContract work- ...Vertex Pharmaceuticals seeks a Senior Director of GCP Operational Quality to lead strategic quality risk management and inspection readiness across clinical... ...to ensure clinical quality outcomes and regulatory compliance. Responsibilities Develop and oversee quality...Senior
- ...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
$155k - $225k
...diseases. Position Overview: The Senior Manager / Associate Director of Clinical Quality Assurance (CQA) will provide leadership... ...oversight, monitor and address vendor quality and compliance risks, and provide pragmatic GCP guidance to study teams. This position...SeniorFull time$227.9k - $308.3k
Overview:The Senior Director, Global Pharmacovigilance Quality Assurance Lead provides executive leadership and independent... ..., and long-term regulatory compliance.This role can be based in Cambridge... ...ICH guidance; working knowledge of GCP interfaces is expected.Demonstrated...SeniorFull timeTemporary workLocal areaRemote workFlexible hours$185k - $235k
OverviewMonte Rosa Therapeutics is seeking a Senior Director Quality GCP to provide strategic oversight of phase-appropriate Quality GCP and GCLP... ...other quality (GxP) procedures. Develop a risk-based GCP compliance program. Support teams in the initiation, review, and...Senior$210k - $290k
The Role: The Senior Director, GMP Quality will build/support and maintain fit-for-purpose quality systems, provide independent quality oversight... ...readiness, data integrity, computerized systems compliance, and alignment with global regulatory expectations, cGMP...SeniorContract workFor contractorsShift work$240k - $285k
...and follow us on X, LinkedIn and Facebook.Role Summary:The Senior Director, Quality Control leads the strategy and execution of Quality... ...product lifecycle management. This role ensures global GMP compliance, inspection readiness, and robust analytical support across...SeniorContract workLocal area$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... ...biotechnology industry.Demonstrated leadership experience in GMP, GCP, and/or GLP environments across development and...SeniorWork at office- ...Dyne Therapeutics seeks a Senior Director, Quality Control to lead QC strategy and execution supporting clinical and commercial manufacturing... ...neuromuscular disease therapeutics. The role ensures GMP compliance, inspection readiness, and analytical oversight across testing...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... ...responsibilities are to ensure both quality and compliance of Deciphera sponsored clinical...SeniorContract work$228k - $342k
Job DescriptionSenior Director, Quality Data, Digital Systems & ComplianceGxP Data... ...position summary:The Senior Director, Quality Data, Digital Systems & Compliance, serves as a pivotal leader within... ...Quality experience (e.g., GMP, GCP, IT). Experience working across...SeniorFull timeWork experience placementSummer workRemote workFlexible hours2 days per week- ...Job Description Job Description Senior Director, Quality Control At Vericel Corporation, we are pioneers in advanced cell therapies for... ...coordination across Quality Control teams and sites. Compliance and Inspection Readiness Ensure Quality Control...SeniorContract workWork at officeMonday to Friday
$250k - $302k
...commutable distance of the office to be considered. The Senior Director, Quality Operations is a senior quality leader responsible for... ...laboratories, and other GxP service providers operate in full compliance with global regulatory requirements and company quality standards...SeniorOngoing contractFull timeContract workWork at officeFlexible hours3 days per week- ...Senior Director role leading enterprise-wide GxP data governance, data integrity, master... ...data management, computerized systems compliance, and quality analytics. This strategic position partners... ...role in global organization ~ GMP, GCP, or IT operational/quality experience...SeniorWork experience placement
- ...of the GVP QA team providing Quality oversight of the global post-... ...This position reports to the Director, Global PV Quality Assurance... ...Summary of Key Responsibilities: Senior Manager, PV QA supports all... ...system, including ensuring compliance with GVP regulations. This includes...SeniorWork experience placementRemote workWorldwide
$185.6k - $232k
...see our website: The Importance of the Role The Director, Corporate Quality, will provide leadership and strategic quality... ...Subject Matter Expert in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) compliance, ensuring that all clinical trial and non-...Full time$137k - $215.27k
...DescriptionOBJECTIVES:Provides quality assurance oversight of the... ...communication of significant quality and compliance risks to key stakeholders and... ...:Provide expertise in GCP compliance interpretation, consultation... ...appropriate solutions to senior management for immediate and...SeniorMinimum wageWork at officeLocal areaImmediate startNight shift- 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
$240k - $305k
...but also preserves vision and quality of life. For more... ...Summary The Executive Director, GCP Quality Assurance provides strategic... ...development and ensures compliance with applicable regulations,... ...Executive Director serves as a senior Quality partner to Clinical...Temporary work$79.56k - $115.72k
...part of Mass General Brigham. Job Summary The Senior Project Manager, reporting to the Administrative Director of Quality and partnering closely with the Chief Quality... ...infrastructure-including Hospital Quality, Compliance, Infection Control, Risk & Safety, and other...SeniorWork at officeRemote workFlexible hoursShift work$258k - $280k
...Job Description Job Description Director/Sr Director Supplier Quality Management Why Work With Us? Location: Hybrid (Needham, MA office) Salary... ..., audit programs, material approval, regulatory compliance, and supplier performance management to ensure consistent...SeniorContract workWork at officeWorldwide- ...Beam Therapeutics seeks a Senior Manager/Associate Director of Clinical Quality Assurance to lead vendor qualification and oversight for clinical service providers... ...and ongoing quality oversight of CROs and GCP/GCLP/GVP service providers Develop and maintain risk...Senior
- 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... ...external stakeholders to protect study subjects and ensure compliance. The role reports to CTO/SVP of Quality and sits on...
$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...$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 ensure they are conducted in compliance with Good Clinical Practice (GCP), applicable global regulations, study...SeniorFull timeSummer workRemote workFlexible hours2 days per week$150k - $170k
...biopharmaceutical and clinical markets. Job Summary: The Sr. Quality Control Manager is responsible for leading and scaling... ...and reagents. This role ensures product quality, regulatory compliance, and operational excellence throughout the manufacturing lifecycle...SeniorHourly payWork at officeFlexible hoursShift work$200k - $260k
...the Company on LinkedIn and X. We are seeking a Director/Senior Director, GMP Quality Assurance Operations. You will be responsible for providing... ...electronic quality systems (eQMS, DMS, LMS), ensuring compliance with Part 11 / Annex 11 and data integrity expectations...SeniorContract workTemporary workFlexible hours
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