CMC Quality Leader: GMP Oversight for Late-Stage Biotech
Alto Neuroscience, Inc.
Alto Neuroscience is seeking a Director/Senior Manager, CMC Quality to oversee GMP compliance for drug substances, drug products, and packaging. The role focuses on quality oversight of GMP manufacturing and Clinical Supply vendors, with audits, change control, and CAPA execution, advancing programs toward registrational and commercial manufacturing. Hybrid Mountain View preferred, remote considered for the right candidate. #J-18808-Ljbffr Alto Neuroscience, Inc.
$165k - $180k
...Director/Senior Manager, CMC Quality to provide quality oversight for Chemistry,... ...products, ensuring GMP compliance and inspection... ...from clinical-stage to commercial-readiness... ...quality experience in biotech/pharma, including... ...Experience supporting late-stage (Phase 3) or...QualityRemote workHome officeFlexible hours- ...Manufacturing, and Controls (CMC) regulatory work.... ...Operations, and Quality. Provide... ...regulatory CMC guidance and oversight to external CDMOs... ...in a growing biotech organization. You... ...2) with pragmatic, stage-appropriate CMC approaches... .... Experience in late phase development (...Quality
- ...seeks an experienced analytical chemistry leader to guide late-stage small molecule programs through... ...analytical method development, validation, CMC documentation, and management of... ...seamless technology transfer, and rigorous quality control, while drafting Module 3 for...Quality
- A leading clinical-stage biotech company is seeking a Director/Senior Director for the Lirentelimab CMC team in Redwood City, CA. This role involves leading a cross-functional team responsible for the CMC project activities from development to commercialization. Candidates...Suggested
$158k - $185k
...mission focused on improving quality of life, increasing potential... ...Senior Manager of Technical QA (GMP) reports to the Senior Director... ...comprehensive GMP quality oversight across the product lifecycle for... ...appropriate Serve as GMP quality for CMC regulatory submissions,...QualityContract workWork at office$211k - $264k
...regulatory NDA/MAA filings for late-stage oncology programs at RevMed.... ..., Clinical, Biostatistics, CMC, Quality, Translational Medicine and... ...years in the pharmaceutical/biotech industry or relevant work... ...drug development including oversight of large, global Phase 3 registrational...QualityFull timeWork experience placementLocal areaWorldwide- Scorpion Therapeutics seeks a Senior Manager of Technical QA (GMP) to oversee quality compliance for oncology biologics, supporting process... ...requires 10+ years in pharma with biologics GMP experience, CMOs oversight, and readiness for regulatory submissions. On-site work is...Quality
$140k - $165k
...Rezolute is a late-stage rare disease biopharmaceutical... ...The Manager, Quality Assurance at... ...deliverables supporting CMC and commercial... ...provides quality oversight for commercial activities... ..., and routine GMP inspections as... ...regulated pharmaceutical/biotech environment...QualityContract workWork at officeLocal areaRemote workFlexible hours- Senior Manager of Technical QA (GMP) Overseeing quality compliance across Summit’s oncology biologics portfolio, supporting process validation... ...management, and post-approval changes. Responsibilities Provide GMP oversight for clinical and commercial manufacturing Manage vendor...Quality
$230k - $280k
...hiring someone to lead our Quality and Analytical... ...therapy programs through GMP manufacturing and into... ...Quality and analytical oversight across our broader pipeline... ...submissions across analytical, CMC, Quality, potency,... ...programs through late-stage or pivotal clinical development...QualityCurrently hiringFlexible hours$199k - $274k
Director, Quality Assurance OperationsRedwood City... ...Inc. is a clinical stage biotechnology... ...operations to support CMC operations and clinical... ...stability testing review, oversight of quality events relating to GMP product, process, or... ....Serves as team leader in quality related...QualityFull timeTemporary workFor contractorsWork experience placementWork at officeFlexible hours3 days per week- Integrated DNA Technologies (IDT) in Sunnyvale, CA, is seeking an on-site Senior Quality Assurance Specialist to provide primary regional QA oversight and support the San Diego facility as needed. The role ensures regulatory compliance, quality system integrity, and collaboration...Quality
- ...Biostatistics to lead statistical activities for late-stage oncology clinical studies. The role... ...management on study design and data quality Provide statistical input to regulatory... .../Biostatistics with 5+ years pharma/biotech experience, or M.S. with 8+ years Hands...Quality
- ...Intuitive. As a global leader in robotic-... ...progressing through late-stage development toward... ...development and validation, CMC documentation, and... ..., and rigorous quality control.... ...ExpectationsProvide technical oversight of external... ...guidelines and GMP requirements.Review...QualityContract workLocal areaWorldwideFlexible hours
$277.52k - $416.28k
...&D, the Head of CMC owns the technical... ...material to GMP clinical supply... ...and Board, this leader will own CMC strategy... ...oversees CDMO quality performance and... ...path to IND. Run stage-gate reviews, maintain... ...cleanly into late-phase... ...records, vendor oversight, and cross-functional...QualityFull timeContract workWork at officeLocal area- H&R Block, Inc. seeks a Multi-Office Leader (Area Experience Leader) to oversee 4-6 retail... ...offices, delivering a consistent, high‑quality client experience across locations. You’... ...Professionals, balance strategic oversight with hands‑on presence, and align priorities...QualityWork at office
- ...salaried employees across regions. You will partner with Legal, HRBPs, and managers to ensure compliant, high-quality outcomes through informal and formal stages. You will mentor others, shape standards, and drive improvements in tools, templates, and workflows while...QualityRemote jobContract work
$164k - $205k
...is seeking a Senior Manager, Quality Validation who will play a key... ...Assurance, providing quality oversight and operational leadership... ...provide broader QA support across GMP operations and quality... ...manufacturing partners.Experience with late-stage development, commercial...QualityFull timeWork at officeLocal areaWorldwide- ...manufacturability from early architecture stages through production ramp. Collaborate... ...solving techniques (8D, DMAIC, etc.). Drive quality improvements through process optimization... .... #IND About Us Coherent is a global leader in lasers, engineered materials and networking...QualityWork at office
$140k - $210k
...study team and internal and external service providers, provides oversight to ensure study delivery and ensure operational excellence.... ...proactively manage risk and contingencies to safeguard timelines, quality and compliance. Develop, manage and track trial timelines and...QualityWork at officeWorldwide- ...to lead global regulatory filings for late-stage oncology programs. This role oversees end... ...dossier sub-teams across clinical, CMC, and quality functions Manage health authority meetings... ...Minimum 12 years pharmaceutical or biotech industry experience Minimum 8 years...Quality
$220k - $235k
...ICSR Management Team is responsible for the oversight of all ICSR Management activities... ...ICA RS for Ascendis Products. Performs Quality Checks of processed ICA RS and provides feedback... ...of Adverse Event intake. Performs late case investigation and risk mitigation strategy...QualityTemporary workWork at officeLocal areaFlexible hours- ...Revolution Medicines seeks an Associate Director of GMP Quality Assurance to oversee quality compliance, batch disposition, and regulatory... ...transfer and inspections. Responsibilities Provide QA oversight and disposition for clinical and commercial small molecule batches...QualityContract work
$100k - $160k
...disease. Orca Bio is a commercial-stage biotechnology company... ...skilled Statistician to join our CMC organization and provide statistical... ...equivalence testing, quality range methods, and mixed-effects... ...development, or QC environment in biotech/pharma.Demonstrated hands-on...QualityFull timeLocal areaRemote work$153k - $178k
...!Vaxcyte is a clinical-stage vaccine innovation company... ...support Vaxcyte's CMC programs by performing... ...working collaboratively with Quality Assurance (QA), to... ...understanding of laboratory GMP requirements who can... ..., providing day-to-day oversight of sample receipt, logging...QualityWork experience placement3 days per week- ...Revolution Medicines seeks a Director of GMP QA Operations to lead quality oversight for assigned clinical and commercial oncology products. The role manages GMP compliance across external manufacturing partners and suppliers, overseeing drug substance through packaged...Quality
$115k - $130k
...Description The Manager, Quality Management Systems (QMS... ...partner closely with CMC Quality Assurance,... ...clinical programs toward late-stage development. The position... ...FDA, ICH, EU GMP, and other global regulatory... ...providing significant oversight of electronic Quality Management...QualityLocal areaFlexible hours- ...leadership, coaching, and strategic direction to hospice or home health services, ensuring high quality, safe care and regulatory compliance. The role emphasizes staffing, budget oversight, onboarding, ongoing staff development, and collaboration with executive leadership to...Quality
- AEG Presents is seeking a Stage Manager to oversee on‑stage production and direct the stage crew during events in Saratoga, CA. The role... ...and maintaining compliance with wage laws while delivering a smooth, high-quality performance environment. #J-18808-Ljbffr AEG PresentsQuality
$194.6k - $285.7k
...Meet the teamAcacia, now a part of Cisco, is a global leader in the design and manufacture of high-speed coherent... ...Drive Product Success: Lead the product through every stage of its life cycle, ensuring specs, quality, market timing, and profitability.Define Requirements...QualityFull timeTemporary workLocal areaFlexible hours
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