GMP QA Lead for DS/DPI & Tech Transfer
Jobleads-US
Revolution Medicines is seeking an Associate Director, GMP Quality Assurance to provide quality oversight and decision-making for DS and DPI manufacturing, testing, and release across late-stage clinical and commercial programs. You will partner with Technical Operations, CMC, Regulatory, and external CDMOs to ensure GMP compliance and data integrity.
The role requires 10+ years in GMP quality with DS/DPI experience, strong leadership, and experience with regulatory filings and inspections.
#J-18808-Ljbffr Jobleads-US- ...Associate Director, GMP Quality AssuranceRevolution... ..., technology transfer, manufacture, testing... ...molecule Drug Substance (DS) and Drug Product Intermediate (DPI). The role ensures... ...Responsibilities include:Provide QA oversight and... ...-impact evaluations.Lead Quality Governance...SuggestedContract workWork at officeWorldwide
- ...European countries. Semnur’s lead program, SP-102 (SEMDEXA™), is... ...Senior Director/Director, CMC/GMP Quality Assurance: We are looking... ...Assurance candidate (CMC-GMP QA) who is experienced in the... ...Support GMP audit activities at DS and DP contract manufacturers including...SuggestedFull timeContract workWorldwide
- ...primary responsibility for QA oversight of Process... ...QA support across GMP operations and... ...including Drug Substance (DS), Drug Product Intermediates (DPI), Bulk Drug Product (... ...Quality leadership. Lead or support the... ...commercial launch, technology transfer, and post-approval...SuggestedWork at officeWorldwide
- ...Medicines is seeking a Senior Manager, Quality Validation who will lead QA oversight of validation activities across CMOs and external... ...PPQ, CPV, and related validation lifecycle activities within a GMP framework. The position requires a scientific/engineering degree...Suggested
- ...A leading technology consulting firm based in California is seeking a Service Delivery Manager to act as the primary interface between... ...leadership. This role involves managing a team of testers, optimizing QA processes, and ensuring effective communication with...Suggested
$180k - $210k
.... The Role We’re seeking a hands‑on Quality & Design Assurance Lead to own our QMS and Design Quality. The position may be filled by... ...401(k) Vision insurance Other Information No H1B or Visa Transfers — must have US Work Authorization or be a US Citizen. Local Candidates...Full timeH1bLocal area- ...The Senior Manager of Clinical Quality Assurance (CQA) at Corcept Therapeutics leads day-to-day quality operations and compliance activities to support our clinical studies. This hybrid role requires on-site presence at least 3 days per week at our Redwood City headquarters...3 days per week
- ...authority for Sagimet Biosciences, leading and building the company's... ...EMA, and GxP guidelines (GCP, GMP, GLP). ·Lead internal quality... ...activities, including drug substance (DS) and drug product (DP) and... ..., scale-up, and technology transfer. ·Provide quality support for...
$243.1k - $314.6k
...to fulfil their aspirations. Join Gilead and help create possible, together.Job DescriptionSr. Director, ERP GMP Quality LeadRole OverviewThe ERP GMP Quality Lead provides quality leadership and independent GMP oversight for the design, deployment, and operation of...Full timeFor contractorsLocal area- ...VIMO INC is seeking a QA Lead (SDET) to oversee testing for a complex web-based health insurance marketplace in Mountain View, California. This role combines hands-on testing (70%) with leadership responsibilities (30%), focusing on building automation and improving quality...
- ...Regulatory Affairs and Quality Control (RA/QC) is responsible for leading and executing global and domestic regulatory strategy, filings,... ..., including iterative AI development, model updates, QMS and GMP requirements, audits and inspections, real‑world performance, and...
$165k - $205k
...accountable for providing strategic and hands‑on GMP quality oversight across Aerogen Pharma's... ..., and applicable complaint processes. Lead Quality oversight of CDMOs, contract... ...analytical development, scale‑up, technology transfer, validation strategy, manufacturing readiness...Contract workTemporary work$185k - $200k
...program Recommend improvements to existing test methods Manage the transfer of test methods to contract laboratories including review and... ...used for testing of proteins and small molecules Proficiency in GMP analytical data review Demonstrated understanding of laboratory...Contract workLocal areaRemote work$210.38k - $272.25k
..., California. Key Responsibilities Lead analytical quality oversight for external... ...programs, analytical methods, and related GMP analytical operations, ensuring... ...programs, analytical method validation, and transfers. Review and approve analytical quality...Contract workLocal areaWorldwide- ...periodic internal audits and management review to identify and remediate gaps. Establish audit readiness across the business Lead the company through customer quality audits and regulatory inspections end to end, from pre-audit preparation through closing CAPAs....For subcontractorWork at office
$167.4k - $209.3k
...protect it for future generations. Role Summary This role will lead the Electrical Systems Validation Test team responsible for... ...background checks, staffing services, and cloud services. Rivian may transfer or store internationally your Candidate Personal Data, including...Full timeContract workTemporary workPart timeLocal areaShift work$115k - $130k
...maintain scalable, phase‑appropriate quality processes aligned with applicable FDA, ICH, EU GMP, and other global regulatory expectations. Support inspection readiness and collaborate with QA colleagues during regulatory inspections and sponsor audits. Manage quality events (...Local areaFlexible hours- ...operational performance in sourcing with a focus on lead generation and validation metrics. The... ...& Knowledge ManagementConduct knowledge transfer and product/market training sessionsHandle... ...preferredTools: Familiarity with CRM systems, MS Excel, PowerPoint, QA/QC exposure...
- ...Redwood City is seeking a Head of Production to own day-to-day manufacturing operations for our endurance multicopter program. You will lead the production, testing, and flight test teams, manage the build schedule, and drive quality, throughput, and on-time delivery as we...
$160k - $240k
...Most Innovative Companies (Top 10, 2025), by CNBC's Disruptor 50, Bloomberg's AI Startups to Watch (2026), Forbes AI 50, and Gartner's Tech Innovators in Agentic AI, Glean continues to accelerate its global impact. With customers across 50+ industries and 1,000+ employees...Work at officeHome officeFlexible hours$186k - $233k
...implementation and lifecycle management across GMP, GCP, GLP, GVP, and GDP environments.... ...integrations, data migrations, and periodic reviews.Lead, develop, and mentor the team, providing... ...optimization.Serve as the Digital Systems QA SME for regulatory inspections and audits,...Full timeLocal areaWorldwide- Unigen, headquartered in Newark, California, is seeking a Quality Supervisor to lead the quality assurance and control functions within an EMS environment, ensuring assemblies comply with IPC standards and customer specifications. This role supervises quality inspectors...
- Programmers.io is seeking a candidate with an Associate or Bachelor's degree in Electronic Technology or related field and 8 years of experience in electrical troubleshooting, assembly, and RF components handling. Familiarity with OTA chambers from R&S, Bluetest, or GTS...
$160.6k - $189k
...per week. Responsibilities: Serve as a Quality Operations lead for complex CMC, commercial, and clinical supply programs by... ...regulatory expectations, and quality agreements Review and approve GMP documentation, including batch records, analytical data,...Full timeContract work3 days per week$145k - $177k
...validate new designs, accelerate engineering learning, and prove that critical robot systems can perform reliably over time. Your Charter Lead the Test & Validation Engineering team while remaining a hands‑on technical leader for the most important robot‑level validation...Temporary workLocal areaFlexible hours- 1X in San Carlos, CA is seeking a hands-on leader to head the Test & Validation Engineering team for the NEO robot family. You will translate engineering objectives into robust test strategies and personally develop complete-robot tests. You will own planning, data collection...
- ...that evaluates design risk and reduces it to acceptable levels for target markets. You will own the reliability strategy, roadmap, and lead a team of reliability engineers across Product Engineering, R&D, and Manufacturing. The role focuses on directing reliability...
- ...QA Manager Location: In-office — Corvus Robotics HQ, Mountain View, CA (this is not a remote or hybrid role) Department: Manufacturing and Operations Employment Type: Full-time About Corvus Every physical good spends time in a warehouse, and every warehouse tracks their...Full timeWork at office
- ...Lead, mentor, and manage the quality assurance team and foster their professional growth Develop, implement, and manage quality assurance... ...and internal standards Drive continuous improvement in QA processes and tooling, including resilient automated testing and...
$69 - $80 per hour
...Professional Job Description This Senior Quality Assurance role leads global quality project and portfolio management across a... ...medical device environments. Experience supporting Quality Systems, QA/QC initiatives, and cross-functional quality transformations....Contract workTemporary workWork at officeRemote workMonday to FridayShift work
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