Associate Director, Quality Control — Clinical & Commercial
Xenon Pharmaceuticals
Xenon Pharmaceuticals invites an experienced Associate Director to lead Quality Control activities across DS/DP programs in line with ICH and cGMP. The role requires managing analytical testing, stability programs, investigations, and collaboration with QA and external labs. The position is based in Boston, MA, with remote options for exceptional candidates and a hybrid schedule requiring two onsite days weekly. #J-18808-Ljbffr Xenon Pharmaceuticals
- ...biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in... ...: We are seeking an experienced Senior Manager/Associate Director, Quality Control to lead Quality Control activities supporting...CommercialTemporary workWork at officeRemote work2 days per week
$185k - $225k
...Position Overview:We are seeking an Associate Director, Quality Control to lead the Beam Massachusetts... ...testing operations supporting Beam’s clinical and late-stage programs, and will help... ...-stage QC group to a late-stage, commercial QC operation.The successful candidate...CommercialFull time$160k - $200k
...is seeking an experienced Associate Director, GMP Quality Assurance Operations to be... ...manufacturing activities supporting clinical programs. This individual... ...from development to commercial manufacturing, site‑to‑... ...investigations, CAPA’s, change control, batch review, CPV, OOS/...CommercialWork at officeRemote work$172k - $202k
...Therapeutics? Entrada is a clinical-stage biopharmaceutical company... ..., and enthusiastic quality control lead excited to be a key contributor... ...specifications at the commercial stage. You will work with CMC... ...attributes and developing associated limits/specifications....CommercialWork at officeLocal areaRemote work1 day per week$153.9k - $230.9k
...DescriptionGeneral/Position SummaryThe Associate Director - Shift Quality Operationsis an advanced... ...Manufacturing, Quality Assurance, Quality Control, MSAT, Engineering, Validation,... ...shop floor QA oversight in a commercial or late-stage clinical manufacturing environment...CommercialFull timeSummer workFlexible hoursShift work$160k - $180k
Associate Director, GMP Quality Batch disposition/release for Clinical Trial Materials and Commercial batches Technical review, quality oversight, and approvals of Master Batch records... ...CMO deviations, CAPA, and Change Controls; open internal shadow records when required...Commercial- Lead Quality Control activities supporting clinical and commercial drug substance and drug product programs in accordance with ICH and cGMP requirements Manage master specifications for starting materials, reference standards, API, and drug products Lead stability activities...CommercialWork at officeRemote work2 days per week
$160k - $180k
Associate Director GMP Quality Reporting to the Head of GMP Quality, you will oversee GMP activities related to Olema’s clinical and commercial products, with a focus on the manufacture of small molecule... ...development and quality control results, Certificate of Analysis...CommercialWork experience placementWork at officeFlexible hours- Xenon Pharmaceuticals seeks an experienced Associate Director of Quality Control to lead analytical testing and stability activities for clinical and commercial drug substances and products. The role emphasizes cross-functional collaboration, regulatory readiness, and a...CommercialRemote work2 days per week
$200k - $217k
Associate Director, GMP Quality Drug Product About Celea Therapeutics Celea Therapeutics... ...is currently in Phase 3 clinical development with active... ...foundation necessary for commercialization. This role will be... ...investigations, CAPAs, change controls, validation protocols and...CommercialContract workFor contractors- ...Pharmaceuticals, headquartered in Needham/Boston area, seeks an experienced Senior Manager/Associate Director, Quality Control to lead QC activities for DS/DP programs across clinical and commercial stages. The role emphasizes reviewing results, stability management, and...CommercialWork at office2 days per week
$190k - $230k
...Description Job Description Associate Director/Director, Technical Quality – Solid Biosciences... ...of high-quality products for clinical trials building towards commercial. Review CDMO manufacturing... ...documentation (batch records, change controls, deviations, etc.) to assess...CommercialTemporary workRemote workFlexible hours$172k - $194k
...communities we serve. We are a clinical-stage company... ...for providing CMC quality oversight of drug substance... ...distribution for non-commercial products that are in... ...hiring the Associate Director, Quality Operations in... ...Batch Production and QC Control Records to ensure all...CommercialContract workLocal areaRemote work$160k - $195k
...The company is advancing clinical programs for Duchenne muscular... ...Facebook.Role Summary:The Associate Director, Quality Management Systems is a... ...supports Dyne’s transition to commercial operations. This role is... ...QMS including document control, records management and training...CommercialLocal area$156.6k - $234.8k
...Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality is responsible for oversight of... ...organization responsible for internal commercial operations in support of GMP... ...intermediates, working cell banks and clinical and commercial drug products internally...CommercialFull timeWork experience placementSummer workRemote workFlexible hoursDay shift2 days per week$94.6k - $141.8k
Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality Assurance is a Quality leader and... ...collaboration with Manufacturing, Quality Control, MSAT, Regulatory Affairs, and... ...including IND/IMPD submissions, clinical supply manufacturing, PPQ, and...Full timeContract workSummer workRemote workFlexible hours2 days per week- Xenon Pharmaceuticals Inc. is seeking an experienced Senior Manager/Associate Director, Quality Control to lead QC activities for clinical and commercial drug substances and products. The role spans early to late clinical phases through PPQ and registration, requiring oversight...CommercialWork at office
- Olema Oncology is seeking an Associate Director, GMP Quality to oversee GMP activities for clinical and commercial products, including QA review of batch records and supplier compliance. This role partners with CMC, Regulatory and Supply Chain, and will be based in SF or...Commercial
$160k - $240k
...OverviewRhythm is a global, commercial-stage... ...OverviewRhythm is seeking an Associate Director, Biostatistics to join... ...and support important clinical development programs.... ...study design, high-quality analyses, and clear interpretation... ..., and quality control of outputs to ensure...CommercialInterim roleWork at office$171k - $236k
...developing, and commercializing important new medicines... ...switch-control kinase inhibitor... ...Deciphera’s platform in clinical studies, QINLOCK... ...patients with TGCT associated with clinically... ...DescriptionThe Associate Director Clinical... ...data review for quality and patient safety...CommercialFlexible hours$198.5k - $311.85k
...empower you to shine? Join us as an Associate Medical Director in our Neuroscience Therapeutic Area... ...Director leads and drives strategy for clinical studies within the overall global clinical... ...medical, scientific, regulatory and commercial issues.Leads or joins multi-...CommercialMinimum wageTemporary workWork at officeLocal areaRemote workNight shift$158.6k - $285.5k
...specifically supporting the Clinical Study Lead in the development... ...ensure the comprehensive data quality of clinical studies to support... ..., Medical Affairs and Commercial.Pay & BenefitsAt Moderna, we... ...****@*****.***. Export Control Notice This position may...CommercialPermanent employmentFull timeWork at officeWork from home- ...Description Description: The Director/Associate Director, Quality Management Systems,... ...QMS including Document Control, Records Management,... ...improvement and the potential of commercialization. The ideal... ...Pharmaceuticals Holdings, Inc. is a clinical-stage biotechnology...Work experience placementWork at officeRemote workNight shift
$240k - $285k
...of disease. The company is advancing clinical programs for Duchenne muscular dystrophy... ...and Facebook.Role Summary:The Senior Director, Quality Control leads the strategy and execution of... ...activities that support clinical and commercial manufacturing, pipeline advancement,...CommercialContract workLocal area$168.75k - $257.8k
Director of QualityCatalent, Inc. is a leading global... ..., as well as multiple commercial-scale lines for capsule... ...hiring a Director of Quality who will provides leadership... ...Development/Quality Control). The responsibility... ...early development to clinical trials and to the...CommercialFull timeContract workLocal area- Stoke Therapeutics, headquartered in Bedford, MA, seeks an Associate Director of Clinical Quality Compliance to oversee GCP/GCLP compliance across clinical studies. This role reports to the VP of Quality and collaborates with Clinical Development, Regulatory, and others...
$252k - $269k
This Clinical Quality Assurance Senior Leader provides strategic leadership and operational oversight... .... We have a portfolio of proprietary commercial products for the treatment of alcohol... ...practices, regulations, guidances and associated industry standard technology platforms...CommercialContract workWork at officeLocal areaWorldwideFlexible hours3 days per week- ...company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics... ...are seeking a Senior Manager/Associate Director, Quality & Supply Chain Systems to join... ...guidance and support on change control activities. Ensure ongoing...CommercialTemporary workWork at office2 days per week
$192k - $215k
...proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit Position Purpose The Associate Director, Clinical Quality Compliance will be a primary quality contact for GCP and GCLP compliance. This role will report into The VP of...Temporary work$184k - $207k
...communities we serve. We are a clinical-stage company currently focused... ...Reporting into the Vice President, Commercial Operations, the Associate Director, Medical, Legal and Regulatory... ..., status tracking, version control, metadata quality, audit trails, and process documentation...CommercialWork at officeLocal areaRemote work
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