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
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Senior Director, Clinical QA & Inspection Readiness in Boston, MA vacancy
$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$160k - $180k
Olema Oncology is seeking a Senior Manager for GCP Clinical Quality to oversee compliance and audit functions within clinical trials. This hybrid... ...skills, and a proven track record in regulatory inspections. The position offers a competitive salary between $160,0...Senior$229.67k - $278.31k
## Senior Dir, Clinical Pharmacology & PharmacometricsCambridge Crossing - MA - USFind out how... ...leader to serve as the Senior Director for Clinical Pharmacology & Pharmacometrics... ...reproducibility, traceability, and inspection-readiness of pharmacometrics and clinical...SeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work- ..., and advocacy groups in all of our clinical and regulatory development strategies... ...a highly experienced and strategic Senior Medical Director, Pharmacovigilance to lead global safety... ...guidelines, and maintain a state of inspection readiness. Represent Pharmacovigilance in...SeniorLocal area
Zevra Therapeutics
Boston, MA2 days ago $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$164.5k - $222.5k
Associate Director, Clinical Quality and Continuous Improvement Overview Provides strategic QA oversight across clinical development procedures... ...quality events, audit and inspection learnings, and regulatory... ...regulations, inspection readiness, and audit/quality systems...Full timeTemporary workLocal areaRemote workFlexible hoursAlnylam
Cambridge, MA4 days ago$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 workWorldwideTakeda Pharmaceutical Company Ltd
Boston, MA2 days ago$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 job$131k - $187k
...Repertoire Immune Medicines is a clinical-stage biotechnology company harnessing the power... ...trials over the next 12-18 months. The Senior Clinical Data Manager will play a... ...ensure timely, accurate, complete, and inspection-ready clinical trial data in accordance with...SeniorTemporary workWork experience placementWork at officeLocal areaFlexible hours3 days per weekRepertoire Immune Medicines Inc.
Cambridge, MA3 days ago$210.9k - $379.2k
...Moderna is seeking an experienced oncology drug developer lead Clinical Development for one or more mRNA-based precision... ...Oversee activities leading to internal cGCP audits and regulatory inspections related to clinical trial conduct Thorough command of FDA...SeniorPermanent employmentWork at officeWork from homeModerna
Cambridge, MA4 days ago$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$66.8k - $124k
...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...SeniorMariana Oncology
Watertown, MA1 day ago$160k - $180k
...second to none. If you're ready to join us at the... .... About the Role Senior Manager, GCP Clinical Quality As the Senior... ...to the Senior Director GCP Quality Assurance... ...regulatory authority inspections and assist with GxP inspection... ...activities: QA review/approval of deviations...SeniorWork at officeFlexible hours2 days per weekOLEMA PHARMACEUTICALS INC
Boston, MA4 days ago$160k - $180k
...About the Role As the Senior Manager, GCP Clinical Quality reporting to the Senior Director GCP Quality Assurance, you... ...during regulatory authority inspections and assist with GxP inspection readiness activities. Oversee... ...conducting internal and external QA audits and developing...SeniorWork at office2 days per week$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 workOruka Therapeutics
Waltham, MA2 days ago- ...Prilenia Prilenia Therapeutics, a clinical-stage biotechnology company... ...neurodevelopmental disorders, is looking for a Director/Senior Director, GCP Quality Assurance... ...end from study start‑up through inspection readiness, and serving as sponsor QA counterpart to our CRO(s) and...SeniorFull timeRemote workFlexible hours
$270k - $295k
...Description of Role Centessa is seeking an experienced Senior Director, Clinical Pharmacology to provide scientific and strategic leadership... ...and organization grow Ensure high-quality, submission-ready documentation aligned with global regulatory standards...SeniorFull timeRemote workCentessa Pharmaceuticals, LLC
Boston, MA13 hours ago$144.8k - $217.2k
...new opportunity to join the Biometrics team as Sr. Manager, Clinical Data Systems. In this role you will report to the Vice President... ..., standards documentation updates, and/or SOPs Support inspection readiness activities as needed Additional duties and responsibilities...SeniorFull timeFlexible hours$275k - $315k
...that enable compliant clinical development, pharmacovigilance... ...compliance risks to Senior Management. Ensure... ...health authority inspections. Lead and provide oversight... ...Ensure inspection readiness at all times,... ...and mentor and coach QA team members. Build...SeniorContract workThe Medical Science Liaison
Newton Center, MA1 day ago$127k - $190.4k
...Senior Manager, GMP Inspection Readiness 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 activities...SeniorContract workWork experience placementSummer workRemote workFlexible hours2 days per weekVer-Tex
Boston, MA3 days ago$145k - $200k
Company Description Job Description The Senior Manager, Clinical Data Management (CDM) leads data management activities for clinical studies... ...on agreed timelines. The Senior Manager also supports inspection readiness and process improvement within the CDM function. Key...SeniorDeciphera Pharmaceuticals
Waltham, MA3 days ago- USWM, LLC is seeking a Lead, QA/QC in Cambridge, MA, responsible for quality oversight, system compliance, and vendor management.... ...systems, documentation management, and participation in regulatory inspections. Successful candidates should demonstrate strong teamwork...Senior
$180.63k - $208.4k
About The Role The Senior Manager, Clinical Data Management oversees clinical trial data management... ...under the supervision of the Director of Clinical Data Science. This role... ...contributes to process optimization and inspection readiness activities. Responsibilities Lead...Senior$310k - $365.8k
...IND and beyond, we are building the clinical infrastructure to match our scientific... ...clinical portfolio. The title and level (Senior Director or VP) will be calibrated to... ...safety reporting compliance and maintain inspection readiness • Contribute to the evolution and...SeniorBlueRock Therapeutics
Cambridge, MA1 day ago- ...time (60% - 80%) experienced Senior QA Auditor to join the team to... ...activities that ensure all clinical research (GCP) and manufacturing... ...working with Healx’s CMC Director to manage review batch records... ...Ensure Healx is inspection ready at all times and conduct self...SeniorPart timeWork at officeRemote workWork from homeHome officeFlexible hours
- ...Senior Clinical Data Manager, Clinical Data Science Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts... ...new hires and/or junior team members Supports regulatory inspection activities Oversees external data providers (e.g., IRT, central...SeniorFor contractorsRemote workFlexible hours
Ionis Brand
Boston, MA13 hours ago $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$315k - $354k
...Senior Medical Director, Clinical Development Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs.... ...culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no...SeniorLocal areaRemote workAmylyx Pharmaceuticals Inc
Cambridge, MA1 day ago- ...Overview Bicara Therapeutics is seeking a Senior Director, Quality Management Systems (QMS),... ...efficiency, and sustained inspection readiness. As a key member of the Quality leadership... ...alongside organizational growth across clinical and commercial activities. This role...SeniorLocal areaRemote work3 days per week
$166.85k - $181.56k
...and participates in, auditing services in support of Alkermes Clinical Programs by conducting clinical site, vendor qualification, internal... ...in the preparation and conduct of regulatory agency inspections Qualifications Basic Requirements: Requirements include...Contract workWork at officeLocal areaImmediate startRemote workAlkermes
Waltham, MA13 hours ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Director, Clinical QA & Inspection Readiness. Be the first to apply!
Related searches
- medical affairs manager Boston, MA
- clinical operations supervisor Boston, MA
- director sr. director clinical operations Boston, MA
- healthcare program manager Boston, MA
- medical sales manager Boston, MA
- medical product manager Boston, MA
- medical assistant supervisor Boston, MA
- medical assistant manager Boston, MA
- medical insurance manager Boston, MA
- project manager health Boston, MA