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$160k - $187k
...Are you ready to join a team committed to making a... ...Reporting to the Executive Director of Quality Assurance, the Senior Manager, Clinical Quality Assurance (CQA)... ...as applicable. Support QA activities that foster... .... Support clinical inspection readiness activities for...SeniorSummer holidayWork at officeHome office$230k - $281k
...Senior Director, Clinical Operations Watertown, MA Patients with adenoid cystic carcinoma (ACC) have waited decades for a treatment... ...issues before they become delays, and always maintain inspection readiness and TMF integrity. Represent Clinical Operations on...Senior$235k - $330k
...Who we are: Kymera is a clinical-stage biotechnology company pioneering the field... ...How you'll make an impact: The Senior Director, Clinical Operations is a leadership... ...trial conduct Accountable for inspection readiness and provides appropriate guidance to...SeniorLocal area$253.33k - $286.67k
...is seeking a seasoned, Sr. Director-level subject matter expert... ...drive the advancement of our clinical programs while upholding our... ...of Clinical Operations, the Senior Director will play a pivotal... ...GCP/ICH guidelines; maintain inspection readiness throughout the trial lifecycle...SeniorFull time$212k - $333.19k
...my knowledge. Job Description About the Role As the Senior Director, Head of Clinical Program Quality & Excellence (TAU), you will drive a... ...clinical program performance, regulatory confidence, and inspection readiness. You will provide quality leadership to key...SeniorMinimum wageFull timeTemporary workLocal 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- ...Senior Clinical Data Manager Odyssey Therapeutics is propelling drug development beyond... ...through close-out. Reporting to the Director of Clinical Data Sciences, you'll independently... ...development, vendor oversight, and inspection readiness as our clinical data sciences...Senior
$265k - $300k
...Biosciences Jade Biosciences is a clinical‑stage biotechnology company... ...Role Overview The Executive Director, Clinical Quality Assurance... ...to assure compliance and inspection readiness with all applicable quality... ...expertise in GCP, GPvP and GLP QA operations, a proactive...Work at officeRemote work$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 week- ...Therapeutics is seeking a Manager, Data Management to oversee clinical data management activities across clinical programs. In this... ...work closely with various departments to ensure high-quality, inspection-ready clinical data. The ideal candidate will have extensive...Senior
$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- ...Our Watertown based client is seeking a Senior Manager, Clinical Data Management to lead endtoend clinical data management activities across... ...vendors, and contribute to process optimization and inspection readiness as our organization continues to grow. Key Responsibilities...Senior
- Merck in Boston is seeking a Clinical Quality Operations Manager to ensure the highest quality in clinical trials through robust management... ...oversee quality by design principles and manage regulatory inspections with full accountability. With a minimum of 6 years in...SeniorRemote job
$82.5k - $166.1k
...Job Description Travel: 80% Overview: Are you ready to take on a pivotal role in transforming healthcare systems? As a Senior Clinical Consultant, you will play a crucial part in shaping the clinical strategy for Post Go-Live (PGL) Readiness Methodology. This...SeniorTemporary workVisa sponsorshipFlexible hours$250k - $290k
Senior GCP Quality Assurance Lead - Permanent - Boston - Remote Take the lead in delivering world‑class QA across clinical development and advancing high‑impact treatments. Proclinical... ...from study initiation through to inspection readiness. The role will also support...SeniorPermanent employmentRemote work$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- ...company dedicated to drug discovery, clinical development, and... ...commercial operations. We are seeking a Director, Quality Assurance, GMP focusing... ...project teams, Health Authority Inspections, suppliers and CMO operational meetings, and QA to QA meetings. Promote a quality...Temporary workWork at officeRelocation package2 days per week
$138k - $190k
...Job Description The Senior Manager, Clinical Quality Assurance is responsible... ...review or revise Clinical QA SOPs to assess consistency... ...Organization (CRO) audits/inspections and ensure acceptability of... ...~ Assist with inspection readiness, and regulatory inspections...SeniorContract work$138.39k - $207.59k
Role Overview Are you ready to lead the systems that keep clinical trials supplied, blinded, and on time? As Senior Manager, RTSM Lead, you will shape how we design and run IRT... ...clinical supply operations. Compliance and Inspection Readiness: Support audits and regulatory...SeniorHourly payTemporary workFlexible hours- ...Prilenia Therapeutics, a clinical‑stage biotechnology... ...at About the role The Director/Sr. Dir, GCP Quality Assurance... ...study start‑up through inspection readiness, and serving as sponsor QA counterpart to our CRO(s... ...‑functional teams and senior leadership. Roles and Responsibilities...SeniorFull timeRemote workFlexible hours
$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, MHRA...SeniorPermanent employmentFull timeWork at officeLocal areaWork from home- Emergent Biosolutions in Canton, MA is searching for a Sr. Manager, QA Compliance to ensure GMP compliance and regulatory inspection readiness. This role is pivotal in leading internal audits and supplier quality oversight, ensuring alignment with global standards. The...Senior
$250k - $290k
Proclinical Group is seeking a Senior GCP Quality Assurance Lead to oversee quality assurance for clinical development initiatives in Boston. This role requires extensive experience in GCP QA within biotech or pharmaceutical environments. The successful candidate will...Senior$160k - $187k
Kura Oncology is seeking a Senior Manager, Clinical Quality Assurance, to spearhead quality oversight within clinical development programs. This... ...to ensure compliance, manage audits, and support inspections. Candidates should have extensive experience in GCP compliance...SeniorRemote job$127k - $190k
Senior Manager, GMP Inspection Readiness May 6, 2026 $127K - $190K 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...SeniorContract workWork experience placementSummer workRemote workFlexible hours2 days per week$270k - $295k
...Senior Director, Clinical Pharmacology Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R... ...and organization grow Ensure high? quality, submission ? ready documentation aligned with global regulatory standards Qualifications...SeniorFull timeRemote work$145k - $200k
...Company Description Job Description The Senior Manager, Clinical Data Management (CDM) leads data management activities for clinical... ...on agreed timelines. The Senior Manager also supports inspection readiness and process improvement within the CDM function. Key...Senior$213.6k - $320.4k
Position Summary The Senior Director, Global Quality Systems... ...for evolution ensuring readiness and sustainability for... .... Partners with QA leadership and enable... ...operating standards, inspection readiness, compliance... ...Experience across preclinical, clinical, and CMC processes,...SeniorContract workWork experience placementSummer workRemote workFlexible hours2 days per week
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