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$137.8k - $206.8k
Job DescriptionGeneral Summary:The Senior Manager, Clinical Study Quality Lead provides study-level... ..., compliance trend analysis, and inspection readiness. The role partners closely with clinical... ...brings direct, hands-on GCP QA experience supporting clinical trials...SeniorFull timeSummer workRemote workFlexible hours2 days per week$235k - $330k
Who we are:Kymera is a clinical-stage biotechnology company pioneering the field of... ...heard.How you’ll make an impact:The Senior Director, Clinical Operations is a leadership... ...clinical trial conductAccountable for inspection readiness and provides appropriate guidance to...SeniorLocal area$230k - $281k
..., we intend to change that. We are a clinical‑stage biopharmaceutical company that... ...Position Summary Remix is seeking a Senior Director, Clinical Operations to lead our clinical... ...delays, and always maintaining inspection readiness and TMF integrity. Represent Clinical...Senior$190.8k - $300.3k
Job DescriptionThe Senior Director, Clinical Science - Hematology is responsible for providing strategic Clinical Science leadership across... ..., company policies, and established procedures.Support inspection readiness and appropriate documentation of Clinical Science...SeniorFull timeFor contractorsLocal areaFlexible hours$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... ...10% Assist with inspection readiness, and regulatory inspections...SeniorContract work$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$245k - $276k
Senior Director, Clinical Data Management Cambridge, MA Amylyx has an audacious mission to usher in... ...Amylyx has assembled an experienced team ready to take action because the... ...applicable regulatory standards, and lead inspection readiness activities Required Qualifications...SeniorWork at officeLocal areaRemote work$130k - $190k
...are seeking a motivated and experienced Clinical Data Management professional to serve... ...portfolio.Reporting to the Senior Director of Data Management, this role is responsible... ...database lock while ensuring high-quality, inspection-ready clinical data. The Manager/Senior...SeniorFull timeInterim role- ...Senior Manager, Clinical Trials Job Location: Irvine, USA | SanFrancisco, USA | Boston, USA | Bothell... ...findings and CAPAs; ensures audit-ready condition of clinical trial documentation... ...enrollment, monitoring, close out and inspection readiness. Understanding of...SeniorTemporary workLocal areaFlexible hours
$210.9k - $379.2k
...Moderna is seeking an experienced oncology drug developer lead Clinical Development for one or more mRNA-based precision... ...rulesOversee activities leading to internal cGCP audits and regulatory inspections related to clinical trial conductThorough command of FDA, MHRA...SeniorPermanent employmentFull timeWork at officeWork from home- Wave Life Sciences in Cambridge, MA seeks a Senior IT Business Analyst to manage GLP/GMP systems, partnering with QA and RA/Reg Ops. You will elicit requirements... ...role emphasizes data integrity, security, and inspection readiness, with heavy involvement in CSV/CSA...Senior
- ...Senior Clinical Data ManagerOdyssey Therapeutics is propelling drug development beyond what... ...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
- Vertex Pharmaceuticals seeks a Senior Manager, Clinical Study Quality Lead to provide study-level GCP QA oversight for assigned trials. This on-site or hybrid role... ...risk-based audit strategies, CAPA, and inspection readiness within sponsor, CRO, or regulated settings....Senior
- ...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
$131k - $187k
...Senior Clinical Data ManagerRepertoire Immune Medicines is a clinical-stage biotechnology company harnessing the power of the human immune... ...external vendors to ensure timely, accurate, complete, and inspection-ready clinical trial data in accordance with GCP, ICH guidelines,...SeniorTemporary workWork experience placementWork at officeLocal areaFlexible hours2 days per week3 days per week$72.8k - $106.56k
...Compliance Operations Manager / Senior Manager Job Category: General... ...reports to the Assistant Director, Compliance Operations, Systems... ..., remediation, and reporting readiness for timely and accurate... ...controls. Support audit readiness, inspections, internal monitoring...SeniorFull timeRemote work- ...Bicara Therapeutics is seeking a Senior QA Specialist, GxP Document... ...role reports to the Sr. Director, GxP Quality Management Systems... ...documentation is accurate, organized, inspection-ready, and maintained in... ...Operations & Supplier Management and Clinical GCP Quality teams to support...SeniorLocal areaRemote work3 days per week
$192.6k - $260.6k
Overview Director, Clinical Quality Risk & Portfolio Oversight leads enterprise... ...systems, audits, inspections, deviations, CAPAs, and quality... ...partnering closely with other QA functions (including GLP and... ...enhance compliance, inspection readiness, and operational...Local areaRemote workShift work$177k - $278.08k
...knowledge.Job DescriptionAbout the roleThe Director, Clinical Program Quality & Excellence (CPQE)... ...assigned clinical programs, ensuring inspection readiness, regulatory compliance, and proactive... ...across the organizationInfluence senior stakeholders to strengthen compliance...Minimum wageTemporary workLocal areaWorldwide$213.6k - $320.4k
...DescriptionPosition Summary:The Senior Director, Global Quality... ...evolution ensuring readiness and sustainability for... ...enterprisePartners with QA leadership and enable... ...operating standards, inspection readiness, compliance... ...Experience across preclinical, clinical, and CMC processes,...SeniorFull timeContract workWork experience placementSummer workRemote workFlexible hours2 days per week$66.8k - $124k
We are seeking an experienced Senior QA Specialist, RLT Manufacturing Operations to join Mariana’s Quality Assurance organization,... ...technology, and radiological safety teams to maintain a robust, inspection-ready quality culture. Illustrative Breadth of Responsibilities:...Senior$138.39k - $207.59k
...Introduction to role: 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... ...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
$168.1k - $268.7k
...As Director, Clinical Quality Assurance Compliance you will lead quality assurance activities... ...priority trials or programs, ensuring inspection readiness and GCP compliance Collaborate... ...Strong GCP expertise gained in a senior Quality Management and / or Clinical...$134.5k - $168.23k
Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader... ...TRUE Innovation!Position Summary:The Senior Manager, Clinical Laboratory... ...Clinical Operations, and vendors.Support inspection readiness, quality activities, process improvements...Senior- ...you can imagine.The Work:The Senior SAP PM & QM Consultant is... ...system design, and go-live readiness across maintenance execution... ...integrated quality operations — from inspection planning and control through... ...VP Operations, Maintenance Directors, QA Managers, and Plant Managers...SeniorFull timeWork experience placementLive inWork at officeLocal areaShift work
$180.8k - $271.2k
...General/Position Summary The Senior Director, CGT Quality Systems,... ...CGT Quality Systems across clinical, launch, and commercial lifecycle... ...expertise across CGT QA to resolve critical challenges... ...including sustainment. Support inspection readiness and audit-related...SeniorSummer workRemote workFlexible hours2 days per week$266k - $344k
Beeline Medicines is a clinical‑stage biotechnology company focused on... ...life fully. Job Summary The Senior Director, GCP Quality Assurance provides... ...maintaining a continuous state of inspection readiness. The Senior Director serves as a senior QA leader and strategic partner...SeniorLocal areaNight shift2 days per week$186.49k - $278.88k
...time R11844 Job Summary In collaboration with the Senior Director of Clinical Management, the Director is responsible for the... ...dossier, and responses to Health Authorities questions) and inspection readiness programs, where appropriate. • Develops strong scientific...Full timeContract workTemporary workLocal areaRemote workWorldwideFlexible hours
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