Associate Director, Quality Control & Regulatory Submissions
Xenon Pharmaceuticals
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 data-driven, fast-paced environment. Based in Boston, MA with potential for remote locations for exceptional candidates; hybrid work requires two onsite days per week. #J-18808-Ljbffr Xenon Pharmaceuticals
$94.6k - $141.8k
...DescriptionGeneral Summary:The Associate Director, GMP Operational Quality Assurance is a Quality... ..., product quality, regulatory expectations, and business... ...Manufacturing, Quality Control, MSAT, Regulatory... ...auditsReview regulatory submissions, as needed, to ensure technical...RegulatoryFull timeContract workSummer workRemote workFlexible hours2 days per week$172k - $202k
...resourceful, and enthusiastic quality control lead excited to be a key... ...standards, and applicable regulatory guidelines. You will support... ...Regulatory to ensure regulatory submission readiness, including but... ...attributes and developing associated limits/specifications....RegulatoryWork at officeLocal areaRemote work1 day per week$160k - $180k
Associate Director, GMP Quality Batch disposition/release for Clinical Trial Materials... ..., CAPA, and Change Controls; open internal shadow records... ...during internal and regulatory inspections Author Quality... ...record review Prior NDA/BLA submission and commercial launch...Regulatory- Lead Quality Control activities supporting clinical and commercial drug substance and drug product... ...on CMC sections of IND, CTA, and NDA submissions Manage review and approval workflows... ...of cGMP and US, Canadian, and EU regulatory environments Excellent oral and written...RegulatoryWork at officeRemote work2 days per week
$160k - $180k
Associate Director GMP Quality Reporting to the Head of GMP Quality, you will oversee GMP... ...development and quality control results, Certificate of Analysis... ...will collaborate with CMC, Regulatory, and Supply Chain teams to prepare submissions, ensure quality and...RegulatoryWork experience placementWork at officeFlexible hours- ...includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary... ...Role: We are seeking an experienced Senior Manager/Associate Director, Quality Control to lead Quality Control activities supporting...RegulatoryTemporary workWork at officeRemote work2 days per week
$200k - $217k
Associate Director, GMP Quality Drug Product About Celea Therapeutics Celea Therapeutics is dedicated... ...systems, support global regulatory inspections and submissions, drive continuous compliance improvements... ...investigations, CAPAs, change controls, validation protocols and...RegulatoryContract workFor contractors$185k - $225k
...from serious diseases.Position Overview:We are seeking an Associate Director, Quality Control to lead the Beam Massachusetts Quality Control team in... ...trails, and data systems remain ready for GMP use and regulatory inspection. Additionally, the Associate Director will...RegulatoryFull time$160k - $200k
...is seeking an experienced Associate Director, GMP Quality Assurance Operations to... ...in compliance with global regulatory requirements, company quality... ..., CAPA’s, change control, batch review, CPV, OOS/OOT... ...with regulatory filings and submissions (IND, IMPD, NDA/BLA, MAA)...RegulatoryWork at officeRemote work$153.9k - $230.9k
...DescriptionGeneral/Position SummaryThe Associate Director - Shift Quality Operationsis an advanced technical... ..., site quality systems, and regulatory expectations while enabling safe, reliable... ...Manufacturing, Quality Assurance, Quality Control, MSAT, Engineering, Validation, and...RegulatoryFull timeSummer workFlexible hoursShift work$156.6k - $234.8k
Job DescriptionGeneral Summary:The Associate Director (AD) Quality Assurance (QA for QC) is an... ...the quality oversight of Quality Control and analytical development activities... ...regulations.Review relevant sections of regulatory submissions; Assist in responses to regulatory...RegulatoryFull timeContract workSummer workFlexible hours$190k - $230k
...Description Job Description Associate Director/Director, Technical Quality – Solid Biosciences... ...global cGMP, GDP, and regulatory requirements. This... ...(batch records, change controls, deviations, etc.) to assess... ...input for regulatory submission packages (pre-IND, IND,...RegulatoryTemporary workRemote workFlexible hours$172k - $194k
...responsible for providing CMC quality oversight of drug... ...We anticipate hiring the Associate Director, Quality Operations in September... ...executed Batch Production and QC Control Records to ensure all... ...and information used in regulatory submissions and validation activities...RegulatoryContract workLocal areaRemote work$142.5k - $256.5k
The RoleThe Associate Director, Quality Control Lab Automation Strategy & Digital Integration is responsible for leading the strategy, implementation... ..., compliant, and aligned with business priorities and regulatory expectations. The Associate Director will work in a...RegulatoryPermanent employmentFull timeWork at officeWork from home$156.6k - $234.8k
General Summary Associate Director (AD) Quality Assurance (QA for QC) provides quality oversight of Quality Control and analytical development activities for Cell & Gene programs... ...protocols and regulations; review regulatory submissions and assist with regulatory responses...RegulatoryContract work- Olema Oncology is seeking an Associate Director, GMP Quality to oversee GMP activities for clinical and... .... This role partners with CMC, Regulatory and Supply Chain, and will be based... ...pharma GMP QA, experience with NDA/BLA submissions, and strong leadership and...Regulatory
$160k - $275k
...program playing a key role in the clinical development plan, regulatory submissions, and overall data strategy. This role requires strategic... ...study objectives and analyze requirements. Oversee and quality control results from statistical programmers or CROs.Contribute...Regulatory$160k - $240k
...OverviewRhythm is seeking an Associate Director, Biostatistics to... ...across clinical, regulatory, safety, data management... ...study design, high-quality analyses, and clear... ...efficacy, and other submission-related or study-level... ...validation, and quality control of outputs to ensure...RegulatoryInterim roleWork at office$163.2k - $244.8k
Job DescriptionGeneral Summary:The Associate Director, Global Submission Management (GSM) is responsible for... ...execution of a portfolio of global regulatory submissions across development and... ...to ensure submission completeness, quality, and complianceIdentifies, manages,...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week$164.5k - $222.5k
Associate Director, Early Development Quality Lead, R&D QAOverview The Early Development Quality Lead is responsible... ...biomarker data that supports IND submissions.Establish and maintain quality... ...system requirements and external regulatory standards including GCP, GLP, ICH...RegulatoryFull timeTemporary workWork experience placementLocal areaRemote workFlexible hours- OverviewThe Associate Director, Nonclinical Writing Innovation... ...generation through regulatory documentation. The position... ..., technology, quality, regulatory, and business... ...governance, quality control, reporting,... ...reports, IBs, regulatory submissions).Demonstrated experience...RegulatoryFull timeContract workTemporary workLocal areaFlexible hours
$180k - $195k
Associate Director, Quality Assurance - CMC Seaport Therapeutics is a clinical-stage biopharmaceutical... ...Good Manufacturing Practice (GMP), regulatory requirements, and company policies.... ...Assist with CMC-related regulatory submissions as required Interacts and communicates...Regulatory- ...Job Description Description: The Director/Associate Director, Quality Management Systems, reporting directly... ...of the QMS including Document Control, Records Management, Training, Deviation... ...-based, and aligned with global regulatory expectations. This position partners...RegulatoryWork experience placementWork at officeRemote workNight shift
- Associate Director, Patient Services, Quality & Compliance Join to apply for the Associate Director, Patient Services... ..., operational excellence, and regulatory compliance by designing and... ...Learning & Development teams. Lead the submission and governance processes for...RegulatoryFull timeWork experience placementLocal area
$163.2k - $244.8k
General Summary The Associate Director, Global Submission Management (GSM) provides strategic oversight and execution of a portfolio of global regulatory submissions across development and lifecycle... ...activities to ensure completeness, quality, and compliance. Identify,...Regulatory$164.45k - $224.79k
Associate Director / Director, Medical Writing, Oncology Position Summary... ...and coordinating high-quality regulatory and clinical documents in... ...prepare, format, and QC, submission-ready clinical and regulatory... ...when appropriate) quality control (QC) and review cycles, incorporating...RegulatoryInterim role- Director, Quality Control (QC) Location: Cambridge, MA (Hybrid) Overview An innovative biotechnology... ...documentation. Quality Systems & Regulatory Readiness Lead QC investigations,... ...stability commitments. Support regulatory submissions including INDs, IMPDs, and BLAs...Regulatory
- ...study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT... ...Role: We are seeking a Senior Manager/Associate Director, Quality & Supply Chain Systems to join our... ...technical guidance and support on change control activities. Ensure ongoing...RegulatoryTemporary workWork at office2 days per week
$210k - $300k
...barriers, together.Opportunity OverviewAs the Senior Director, Analytical Development and Quality Control, you will provide strategic and technical... ..., timely delivery of analytical data to support regulatory submissions and commercial supply.You will lead and develop...RegulatoryContract workWork at office- ...Pharmaceuticals Incorporated is seeking an Associate Director of Chemistry Manufacturing Controls (CMC) to lead global regulatory strategies for biologics. You will author, review, and deliver high-quality regulatory submissions and serve as the primary CMC interface...Regulatory
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