Senior Director, GxP QMS & Inspection Readiness
$254k - $295kScorpion Therapeutics
Scorpion Therapeutics is seeking a qualified candidate to design and implement an integrated Quality Management System (QMS) to support GxP activities. You will partner with GMP and GCP Quality leads, lead QMS governance, and ensure ongoing compliance with regulatory standards. The ideal candidate will possess a Bachelor’s degree in life sciences, 10+ years of GxP Quality experience, and have proven leadership abilities within a fast-paced biotech environment. The compensation range is $254K - $295K. #J-18808-Ljbffr Scorpion Therapeutics
$254k - $295k
...and continuously improve an integrated QMS to support all GxP activities. Partner with GMP and GCP... ...QMS activities (e.g., QMR, audits, inspections) with Quality leads. Establish frameworks... ...tools to support ongoing inspection readiness. Partner with GMP and GCP Quality...Senior$215k - $260k
Job Summary The Senior Director, U.S. Quality is responsible for leading... ...regulatory requirements; lead U.S. inspection readiness and support regulatory... ...Quality Management Systems (QMS), including SOPs, policies,... ...regulatory requirements (FDA, GxP). Proven ability to execute...SeniorTemporary work$215k - $260k
...direct impact.Job SummaryThe Senior Director, U.S. Quality is responsible... ...requirements; lead U.S. inspection readiness and support regulatory interactions... ...Quality Management Systems (QMS), including SOPs, policies,... ...requirements (FDA, GxP)Proven ability to execute strategy...SeniorContract workTemporary workWork experience placementShift work- ...implementation of Veeva Vault (CTMS, eTMF, and QMS). This role requires managing project... ...and a strong understanding of GxP guidelines. You will bridge the gap between... ...business stakeholders to ensure operational success and inspection readiness. #J-18808-Ljbffr Talent GroupsSenior
- ...leadership/oversight to ensure global QMS health, integrity, and effectiveness across all GxP domains, products, modalities,... ...roadmap (e.g., scaling, digital readiness, emerging technologies/novel... ...translate into operating standards and inspection readiness. Lead, develop, and...Senior
- ...Consultant for a biotech client preparing for an FDA inspection. This critical director-level position involves maturing the CSV program and ensuring audit readiness. Candidates should have over 12 years of experience in GxP CSV / Validation and strong SaaS validation...
$216k - $324k
Job Description The Senior Director, Manufacturing Technical Sciences QA is... ...as well as Vertex’s QMS for products throughout the life... ...and support Health Authority inspections, respond to information requests... ...knowledge and experience across GXP life cycle in Cell & Gene...SeniorSummer workRemote workFlexible hours2 days per week3 days per week$213.6k - $320.4k
## Senior Director, Quality Systems/QMSApplylocations: Boston... ...execution throughout GxP domains, various products... ...throughout the global QMS.**Key Responsibilities... ...evolution ensuring readiness and sustainability for... ...operating standards, inspection readiness, compliance...SeniorContract workWork experience placementSummer workRemote workFlexible hours2 days per week- ...high-performing process development team to develop commercial-ready manufacturing processes. Partner with Research to develop 3D stem... ...submissions (IND, BLA), and support regulatory Q&A and inspections. Collaborate with multidisciplinary teams to deliver pivotal and...Senior
$250k - $300k
...clinical and commercial product. As the Senior Director, Late-Stage Cell Therapy Process... ...development team to develop commercial ready manufacturing processes. You will play... ...IND, BLA) and support regulatory Q&A and inspections. Collaborate and influence partners across...Senior$105k - $128k
Position Overview Senior QA Specialist, GxP Document Control and Quality Systems. Hybrid (Boston;... ...document control in the electronic QMS (development, formatting, routing, review... ...outside the formal QMS for inspection readiness and easy retrieval. Support the GxP...SeniorRemote work3 days per week- Senior Manager, GMP Inspection Readiness Role Responsibilities Drive real-time GMP inspection readiness across Vertex’s CMO network (small molecule, biologics... ...(written/verbal/presentation/facilitation). Broad GxP knowledge; strong GMP regulatory knowledge and application...Senior
$263k - $321k
...Position Summary Prime Medicine is seeking an experienced Senior Director, Biometrics to serve as the senior biostatistics leader... ...SDTM/ADaM expectations) Ensure data quality, integrity, and inspection readiness across all clinical programs. Provide input into protocol...SeniorFull timeTemporary workInterim role- ...Bicara Therapeutics is seeking a Senior QA Specialist, GxP Document Control and Quality... ...Quality Management System (QMS). This role reports to the Sr. Director, GxP Quality Management Systems... ...documentation is accurate, organized, inspection‑ready, and maintained in accordance...SeniorLocal areaRemote work3 days per week
$227.4k - $284.26k
...Senior Director, Biostatistics Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the... .... Shape briefing book content, respond to RFIs and ensure inspection readiness. Lead or contribute to departmental initiatives for process...SeniorFlexible hours- Scorpion Therapeutics in Boston is seeking a Senior Manager for GMP Inspection Readiness. This position involves driving inspection readiness across the CMO network for small molecules and biologics, developing and enhancing readiness plans, and supporting regulatory inspections...Senior
$127k - $190k
Senior Manager, GMP Inspection Readiness May 6, 2026 $127K - $190K Job Description GENERAL/POSITION SUMMARY: The Senior Manager, GMP Inspection Readiness... ...provide clear updates in real time. Broad knowledge of GxP requirements across product lifecycles , with strong...SeniorContract workWork experience placementSummer workRemote workFlexible hours2 days per week- About the Role We are seeking a Director/Senior Director, CMC, Drug Substance to join our team. The Director/Senior Director will help manage... ...as the subject‑matter expert and participate in audits and inspections of API CDMOs in conjunction with Quality Assurance....SeniorTemporary workRemote workFlexible hours2 days per week
$160k - $180k
Senior Manager, GCP Clinical Quality (Hybrid) Responsibilities Perform internal... .... Support regulatory authority inspections and assist with GxP inspection readiness. Lead quality oversight for... ...Support Quality Management System (QMS), including QA review/approval of...Senior$212k - $333.19k
...requirements. Responsible for leading or supporting initiatives or projects improving Medical Review activities and processes. Support inspections and audits related to medical review and case assessment, and develop and implement Corrective and Preventive Actions (CAPA)....SeniorFull timeTemporary workLocal areaRemote workFlexible hours$245k - $302k
...benefit to patients. Job Summary: The Senior Director, Pharmacovigilance (PV) Sciences... ...safety database providers. Ensure database readiness and compliance with global regulatory... ...Proactively establish and maintain inspection readiness for Health Authority audits...SeniorHourly payFull timeContract workLocal areaFlexible hours$250k - $290k
Senior GCP Quality Assurance Lead - Permanent - Boston - Remote Take... ...study initiation through to inspection readiness. The role will also support... ...protocol deviations and GxP non‑conformances, and drive CAPA... ...the Quality Management System (QMS). Contribute to SOP...SeniorPermanent employmentRemote work$160k - $180k
...About the Role As the Senior Manager, GCP Clinical Quality... ...reporting to the Senior Director GCP Quality Assurance,... ...regulatory authority inspections and assist with GxP inspection readiness activities. Oversee quality... ...Management System (QMS) activities, including review...SeniorWork at office2 days per week$175k - $195k
...pain and bipolar disorder. Your Impact The Senior Technical Operations Manager plays a... ...shipments, and documentation Ensure operational readiness to support regulatory milestones and... ...and external vendors in a regulated GMP/GxP environment Strong project management and...SeniorFull timeWork at officeLocal areaImmediate start$286.9k
...Senior Principal Scientist (Senior Medical Director) Translational Medicine, Immunology Translational Medicine in our Research & Development Division is responsible... ...science of preclinical discovery into compounds ready for assessment in large clinical populations. We are...SeniorFor contractorsWork at officeRemote workWorldwideMonday to FridayMonday to ThursdayShift work3 days per week$210.9k - $379.2k
...Role Overview The Global Medical Director at Moderna leads medical affairs strategy across the oncology portfolio, spanning from... ...Patient Advocacy) ensuring timely delivery. Lead global launch readiness of oncology assets, including medical training, evidence...SeniorWorldwide- ...About the role The Director/Sr. Dir, GCP Quality Assurance... ...start‑up through inspection readiness, and serving as sponsor... ...‑functional teams and senior leadership. Roles and... ...deviations and GxP non‑conformances, drive... ...national regulations. QMS & Cross‑Functional Leadership...SeniorFull timeRemote workFlexible hours
$210.9k - $379.2k
...patients' lives worldwide. Moderna is seeking a Global Medical Director to lead medical affairs strategy across our Oncology portfolio... ...timely execution of deliverables. Leading global launch readiness for oncology assets, including medical training, evidence generation...SeniorPermanent employmentWork at officeWork from homeWorldwide$252k - $378k
...General Summary The Senior Director (non-MD) serves as a US Medical Affairs asset lead responsible for strategic planning and execution... ...Development, and Corporate Communications for aligned launch readiness. Design and execute medical evidence generation initiatives...SeniorShift work$252k - $269k
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...Senior
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