Senior Director, Clinical QA & Inspection Readiness
$252k - $269kAlkermes
Alkermes is seeking a Clinical Quality Assurance Senior Leader in Boston, MA. This role involves strategic leadership and operational oversight of GCP/GLP/GVP quality programs to ensure compliance in clinical trials. Candidates must have 15+ years of experience in clinical sponsor activity and 8+ years in GCP management. The position offers a salary range of $252,000-$269,000 annually plus performance bonuses and a competitive benefits package. #J-18808-Ljbffr Alkermes
$252k - $269k
Clinical Quality Assurance Senior Leader provides strategic leadership and operational oversight of Alkermes... ...leader ensures the organization is ready for inspections, implements and manages risk-based... ...requires an experienced Clinical QA Senior leader who can build high‑...SeniorLocal areaWorldwide- A clinical-stage biotechnology company is seeking a Senior Director of Quality Assurance GCP to develop a robust quality framework. This role involves overseeing... ..., managing quality events, and ensuring inspection readiness. Candidates should have a degree in life sciences...Senior
$265k - $300k
...Executive Director, Clinical Quality Assurance Boston; San Francisco; Seattle About Jade Biosciences... ...to assure compliance and inspection readiness with all applicable quality requirements... ...hands‑on expertise in GCP, GPvP and GLP QA operations, a proactive approach to...SuggestedWork at officeRemote work$265k - $300k
A biopharmaceutical company is seeking an Executive Director, Clinical Quality Assurance to lead QA operations focused on GCP, GPvP, and GLP compliance. The ideal candidate will have extensive experience in regulatory practices, strong problem-solving skills, and the ability...SeniorRemote work$137k - $215.27k
...therapies to patients worldwide. Objective / Purpose: The Senior Manager, Clinical Partner Outsourcing (CPO) ensures seamless execution of... ...internal policies and procedures, regulations, support inspection readiness of all regulated activities. Lead or participate in...SeniorMinimum wageFull timeContract workTemporary workLocal areaImmediate startRemote workWorldwide$127k - $190.4k
Vertex Pharmaceuticals is seeking a Senior Manager, GMP Inspection Readiness in Boston, MA. This role involves leading GMP inspection readiness activities across their manufacturing network, developing inspection readiness plans, and ensuring compliance with regulatory...Senior- ...Responsibilities: Real-time Inspection Readiness. Develop, manage and contribute to ongoing maturity of GMP and GDP Inspection Readiness Plans associated with regulatory filings and real-time inspection readiness activities. Work directly with CMOs and...SeniorWork experience placement
$140k - $198k
...pipeline currently includes four clinical assets spanning all phases... ...a hands-on strategic Senior Manager, Clinical Statistical... ...Programmer, reporting to our Director of Biostatistics. The ideal... ...remain current, validated, and inspection readiness. Lead the production of recurring...SeniorSummer workWork at officeFlexible hours$109.15k - $126.85k
...Senior QA Specialist, RLT Manufacturing Operations We are seeking an experienced Senior QA Specialist, RLT Manufacturing Operations... ..., and radiological safety teams to maintain a robust, inspection-ready quality culture. Illustrative Breadth of Responsibilities...Senior$140.3k - $189.7k
Overview The Sr. Manager, Clinical Operations is accountable for the end-to-end clinical... ..., and conduct of, Health Authority Inspections and internal QA audits. Ensure that the trial team... ...in a constant state of inspection-readiness, collaborating with R&D Quality to ensure...SeniorFull timeTemporary workLocal areaFlexible hours$190k - $252k
...Kelonia Therapeutics, we aren’t just a clinical company; we’re trailblazers in... ...improvements Quality, Compliance & Inspection Readiness Ensure study execution aligns with... ...advanced degree preferred with 10+ years (Director) / 12+ years (Senior Director) in clinical operations...SeniorFull timeFlexible hours$190k - $232.8k
...company is advancing clinical programs for Duchenne... ...Role Summary: The Director, Clinical Quality Assurance... ...; managing audits, inspections, and vendor oversight;... ..., inspection readiness, and sponsor oversight... ...combination of PV and QA experience) Deep...Local areaFlexible hours- ...Director, Clinical Quality Assurance The Director, Clinical Quality Assurance... ...reporting directly to the Senior Director, Head of Quality,... ...the following clinical QA areas: Vendor Quality, QA... ...assure GCP compliance and inspection readiness with regards to all quality...Work experience placementWork at officeNight shift
$213k - $240k
...company culture. Job Title: Director, Clinical Quality Assurance Location:... ...execution and vendor performance, and drive inspection readiness for global health authority... ...requirements. The Director, Clinical QA will provide proactive quality input...Remote work$131.04k - $196.55k
Senior Manager, GCP & GVP, QA Agios Pharmaceuticals is searching for a dynamic Sr. Manager, GCP & GVP... ...and non‑interventional clinical trials in accordance with applicable... ...assure compliance with GVP and GCP and inspection readiness. Responsibilities Collaborate cross...SeniorRemote work$127k - $190.4k
...Job Description GENERAL/POSITION SUMMARY: The Senior Manager, GMP Inspection Readiness plays a key role in ensuring ongoing inspection readiness across Vertex and our manufacturing network. This individual will lead and enhance real-time GMP inspection readiness...SeniorContract workWork experience placementSummer workRemote workFlexible hours2 days per week$148.3k - $241.9k
Overview The Senior Clinical Study Lead (CSL) is accountable for the global execution of assigned large and/or complex clinical trials... ...per the scope of work Ensures clinical project audit and inspection readiness through the study lifecycle and supports internal or...SeniorContract work$265k - $300k
...A clinical-stage biotechnology company is seeking an Executive Director of Clinical Quality Assurance to oversee quality assurance... ...include providing QA oversight, leading risk-based... ...strategies, and maintaining inspection readiness. The expected salary range is...Remote work$131.04k - $196.55k
...leading pharmaceutical company is seeking a Senior Manager, GCP & GVP Quality Assurance to... ...compliance of pharmacovigilance and clinical trials. This role includes developing audit... ...regulatory adherence, and preparing for inspections. The ideal candidate has 4-6+ years of...SeniorRemote work$142.4k - $224.1k
Job Description Our Clinical Research and Pharmacovigilance... ...quality management and inspection management activities.... ...ongoing inspection readiness as well as preparing for... ...our research division QA and acting as the link... ...compliance risks to Company Senior Management. Develops...For contractorsWorldwide$315k - $354k
...to the communities we serve. We are a clinical-stage company currently focused on post... ...has assembled an experienced team ready to take action because the communities... ...apply.The OpportunityAmylyx is seeking a Senior Medical Director, Clinical Development to provide strategic...SeniorLocal areaRemote work- Exyte is looking for a Senior QA/QC CSA Engineer in Boston, MA, to ensure compliance with project design documents and safety protocols... ...high-tech facility construction. The role involves conducting inspections, managing Non-Conformance Reports, and maintaining project...Senior
- ...Functions Develop and maintain quality assurance (QA) systems to ensure high performance and... ...laboratory is prepared for regulatory reviews and inspections (e.g., TJC, CAP, FACT). Oversee the coordination of clinical trials in collaboration with principal investigators...SeniorLocal areaShift work
- Reporting directly to the Chief Medical Officer (CMO), the Senior Director of Clinical Operations will serve as the company’s senior... ...monitoring plans (risk‑based and on‑site), eTMF setup and inspection readiness, and quality oversight frameworks. Ensure GCP compliance...SeniorContract workFor contractorsFlexible hours
$143k - $175k
...perspectives, and experiences to join our team. What You’ll Do: The Senior Clinical Oversight Manager (COM) is responsible for executing the... ...ensuring Oversight CRAs maintain their sites/studies as inspection ready, including the TMF, for health authority inspections...SeniorFull timeWork at officeLocal areaFlexible hours3 days per week- ...Associate Director / Director, Clinical Operations Location: Hybrid - Boston We are partnering with an innovative biotechnology company seeking... ...financial performance while ensuring compliance and inspection readiness What We're Looking For Bachelor’s degree (or...
$55 - $65 per hour
...Operational Area Senior Quality Specialist The operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations... ...in corporate audits and external inspections as needed Communicates proactively with...SeniorContract workTemporary workWork at office$94k - $111k
...Preclinical laboratory QA Staff (Advisor) ensures compliance... ...R&D Preclinical and clinical lab functions at defined sites... ...robust quality systems, lead inspection readiness activities, manage regulatory... ...Facility Management and Study Director and Principal Investigator as...SeniorLocal area$170k - $190k
...Biosciences Jade Biosciences is a clinical‑stage biotechnology company focused on... ...LinkedIn. Role Overview The Associate Director, Clinical Site Budgets & Payments will... ...accruals, reconciliation, and inspection‑readiness. The successful candidate must be equally...Contract workRemote work- ...ABOUT GLYCOERA GlycoEra is a clinical-stage biopharmaceutical company based in Zurich... ...team to match our ambition. The Senior Director, Clinical Operations will provide... ...clinical operations strategy, execution, inspection readiness, and governance of external providers...SeniorFor contractors
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