Director, Quality Assurance
$275.66k - $310.85kMirum Pharmaceuticals
Senior Director, Development Quality (GMP)Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.Position SummaryWe are seeking an experienced Senior Director, Development Quality (GMP) who will be responsible for providing strategic and operational quality oversight for product development activities from early development through commercialization. This role ensures compliance with global GMP regulations and supports development, scale-up, and technology transfer of drug substance, drug product, and finished product.This position requires extensive experience in GMP Quality Assurance, including oversight of CMC development, clinical manufacturing, and global supply, along with strong knowledge of regulatory expectations across all phases of development.Job Functions/ResponsibilitiesServe as a strategic Quality leader to support development and advancement of a compliant, phase-appropriate, and collaborative GMP quality culture across development and technical operations.Provide QA oversight of product development lifecycle activities, including drug substance (DS), drug product (DP), and finished product (FP) from early development through commercialization.Oversee and support GMP quality systems applicable to development, including deviations, CAPAs, change control, investigations, and product complaints.Provide QA support for clinical manufacturing, including batch record review/disposition and release of DS, DP, and FP for clinical use.Ensure quality oversight of process development, technology transfer, scale-up, and validation activities.Support preparation, review, and approval of CMC sections for regulatory submissions (e.g., IND, NDA, MAA) and responses to regulatory authority questions.Interface with regulatory agencies and support GMP inspections, including pre-approval inspections (PAIs) and general GMP inspections.Identify compliance risks within development and manufacturing activities and escalate issues to appropriate levels of management.Oversee and support GMP vendor management, including qualification, auditing, and ongoing oversight of CMOs, laboratories, and suppliers.Establish and maintain Quality/Technical Agreements with CMOs and development partners.Support new product introduction, acquisition, and integration activities from a GMP quality perspective.Support development and oversight of stability programs for investigational and commercial products.Develop, track, and trend quality metrics for reporting to Quality Management Review (QMR) and Annual Product Reviews (APR/APQR).Ensure inspection readiness across development and clinical manufacturing operations.Collaborate cross-functionally with Technical Operations, CMC, Regulatory Affairs, Supply Chain, and Manufacturing.Build, mentor, and lead a high-performing Development Quality team.Champion a culture of quality and inspection readiness across internal and external operationsQualificationsEducation /Experience:Bachelor's degree in a scientific discipline; advanced degree (MS, PhD) preferred.15+ years of experience in the pharmaceutical/biotech industry, including 12+ years in GMP Quality Assurance.Strong expertise in global GMP regulations, including FDA, EMA (EudraLex), ICH guidelines, and Good Manufacturing Practices.Demonstrated experience supporting product development from early stage through commercialization, including clinical manufacturing.Strong knowledge of CMC development, process validation, technology transfer, and manufacturing operations.Experience supporting regulatory submissions (IND, NDA, MAA) and health authority inspections, including PAIs.Experience with GMP vendor oversight, including CMOs and contract laboratories.Proven leadership experience with the ability to build and develop high-performing teams.Strong understanding of pharmaceutical supply chain and lifecycle management.Experience with inspection readiness and continuous improvement of quality systems.Excellent communication, collaboration, and risk management skills.Strong knowledge of FDA, EMA, ROW CGMP regulations, and ICH guidanceThe salary range for this position is $275,657 to $310,847 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.
$210.38k - $272.25k
...in Foster City, California.Key Responsibilities:Lead analytical quality oversight for external QC testing laboratories, stability... ...lifecycle and regulatory priorities, and lead the Analytical Quality Assurance team while fostering accountability, collaboration, and a...SuggestedFull timeContract workFor contractorsLocal areaWorldwide$220k - $240k
...with other individuals who embody our values: care, be real, get it done, and have fun, seriously.POSITION SUMMARYThe Director, GMP Quality Assurance is responsible for the global oversight and management of GMP Quality Assurance operations supporting development and commercial...SuggestedContract workLocal area- ...Senior Director, Quality As the Senior Director, Quality, you will serve as the quality authority for Sagimet Biosciences, leading and building the company's Quality Management System (QMS) and providing oversight of all Manufacturing Quality activities across the clinical...Suggested
Sagimet Biosciences
San Mateo, CA4 days ago $210.38k - $272.25k
...their aspirations. Join Gilead and help create possible, together.Job DescriptionDirector, Global Supplier Quality Management ProgramPosition ImpactThe Director, Global Supplier Quality Management Program serves as the Global Process Owner (GPO) for Supplier Quality Management...SuggestedFull timeFor contractorsLocal area$190k - $205k
...Mirum Pharmaceuticals seeks an Associate Director of GCP/GVP/GLP-QA to support clinical studies. This role involves ensuring compliance with quality standards and overseeing GCP quality assurance activities. The ideal candidate will possess a scientific Bachelor's degree...SuggestedMirum Pharmaceuticals
Foster, CA19 hours ago$210.38k - $272.25k
...and help create possible, together. Job Description Director, Product Quality Complaints Gilead Sciences, Inc. is a research-based biopharmaceutical... ...diseases. Working in QA at Gilead Quality Assurance delivers on Gilead’s commitment to bring life-changing...Local areaWorldwideBiopharma Careers
Foster, CA19 hours ago- ...possible, together.Job DescriptionAssociate Director, Global Supplier QualityPosition SummaryThe Associate Director, Global Supplier Quality serves as the global program owner... ...with 10+ years of experience in Quality Assurance, Supplier Quality, Quality Systems, Compliance...Full timeContract workFor contractorsLocal area
$190k - $205k
...continuous improvement of policies and procedures to maintain quality standards aligned with global regulatory and company guidelines... ...organization.Partner with cross-functional stakeholders (Quality Assurance, Manufacturing, Supply Chain, and IT) to define system...Local area- ...Foster City). You will be on site Tuesday, Wednesday, Thursday. For non-local talent, we are open to remote.As an Associate Director, Quality Assurance Compliance at Gilead you will have the following responsibilities:Inspection Operation and Logistics (Foster City):...Full timeFor contractorsWork at officeLocal areaRemote work
$211k - $264k
...with urgency and hold ourselves to a high standard of rigor—all in service of patients.The Opportunity:The Director, Good Laboratory Practice Quality Assurance (GLP QA) is responsible for ensuring Good Laboratory Practices (GLP) compliance at RevMed and external vendors...Full timeLocal areaWorldwide$273k - $290k
...IND submission slated for the second half of this year, we are at a pivotal inflection point.We are looking for a Senior Director of Quality Assurance to build a pragmatic, inspection-ready quality function for clinical-stage operations. You will own insitro's approach...Home officeFlexible hours3 days per week$240k - $300k
...the US and China and capitalizing on the strengths of each geographic location.Position Summary:We are seeking a Senior Director of GMP Quality Assurance (QA) to serve as a senior quality leader responsible for developing, leading, and executing the global GMP QA strategy...Contract work$229k - $268k
...our pipeline of high-fidelity vaccines. Vaxcyte is looking for an energetic and talented individual to join our Quality Assurance team as a Senior Director. This role carries dual accountability: providing direct QA support to the analytical operations based in Switzerland...Contract work$157.59k - $203.94k
...challenges of our day and improving the lives of patients for generations to come. As a Senior Manager, Quality Assurance at Gilead you will report to the Associate Director, Quality Assurance within the PDM External Quality organization. This position is dedicated to...Full timeContract workFor contractorsLocal area$265k - $331k
...in the RAS signaling pathway.The Opportunity:The Executive Director, GxP Quality & Compliance is a senior leadership role responsible for defining... ...decisions.Partner collaboratively with PDM, Quality Assurance, Regulatory Affairs, Clinical Development, Life Cycle Management...Full timeLocal area$300k - $350k
...demonstrating integrity, accountability, equality and clarity across communications and decision making.Summary:The Executive Director, Quality Assurance, External Manufacturing is responsible for leading the External Manufacturing Quality function and executing the quality...Contract workRelocationRelocation package2 days per week3 days per week$200k - $230k
Job Description:Allogene is seeking a Product Quality Leader (PQL) to oversee Allogene’s CAR T programs, including starting materials (cell starting materials, viral vectors, and nucleic acids programs). Allogene plans to create an outstanding product design, characterization...Full timeContract workWork experience placementWork at officeLocal area- ...Your Contribution: As Quality Manager you will communicate the Quality Mind-set, policies, procedures, specifications, government and industry standards to ensure the product and manufacturing processes is in alignment with those requirements. You are going to be...Currently hiring
MAHLE GmbH
Belmont, CAa month ago - Erasca, a clinical-stage precision oncology company, is seeking a Senior/Executive Director of Quality Assurance GCP to lead GCP activities and oversee QAGCP operations across Phase 1-3 programs, regulatory submissions, and future launches. Reporting to the COO, this role...Remote job
$240k - $300k
...unmet need, including cardiovascular, metabolic, and pulmonary conditions. Position Summary We are seeking a Senior Director of GMP Quality Assurance (QA) to serve as a senior quality leader responsible for developing, leading, and executing the global GMP QA strategy...Contract work- JLSa2 Therapeutics, Inc. in South San Francisco is seeking a Director of Quality Control to lead QC strategy and execution in a fast-paced biotech setting. This role coordinates Analytical Development, QA, and external testing labs to ensure clinical-grade products are...
$215.6k - $266.3k
...focused - Work together to fearlessly uncover new possibilities The Director, CMC QA will report to the Senior Director of CMC QA and be... ...Operations, developing and implementing Ultragenyx CMC Quality approach for assigned programs, and working with colleagues to...Full timeWork at officeLocal areaFlexible hours2 days per week3 days per week- A clinical-stage biotechnology company in Redwood City, CA, seeks a Sr. Director of Analytical Development and Quality Control. This role involves providing technical leadership for methods development and oversight of CMC activities. Candidates must have over 15 years...
$190k - $230k
...diseases and other non-oncology related diseases. We are seeking a Director of Quality Control to lead and oversee QC strategy and execution in a... ...key liaison between JLSa2’s Analytical Development, Quality Assurance, and external CDMOs/testing laboratories to ensure that...Contract work$186k - $233k
...mutations in the RAS signaling pathway.The Opportunity:Lead the Global Quality Systems Monitoring & Excellence program to ensure effective... ...; Master's degree preferred.10+ years of progressive Quality Assurance/Quality Systems experience in the biotechnology, pharmaceutical...Full timeLocal area$186k - $233k
...cancers harboring mutations in the RAS signaling pathway.The Opportunity:Revolution Medicines is seeking an Associate Director, Clinical Quality Assurance, who will play a key role within Quality Assurance and is responsible for providing leadership and compliance...Full timeLocal area- ...manual testing cycles. Identify, document, and track bugs through to resolution. Collaborate with engineers to maintain high code quality and modularity. Qualifications Bachelor’s in Computer Science or related field with 10 years of experience. Deep understanding of testing...Work at officeRemote work
Eyetell, Inc.
San Mateo, CA1 day ago $69 - $80 per hour
...Senior Quality Assurance SpecialistThe Senior Quality Assurance Specialist leads global quality project and portfolio management efforts, ensuring that quality initiatives are planned, executed, and monitored effectively across a regulated, GxP environment. This role drives...Contract workTemporary workWork at officeRemote workMonday to FridayActalent
San Mateo, CA2 days ago- ...clinical and commercial milestones, we are seeking a Senior Director of Quality Systems and Compliance to shape and lead our quality and compliance... ...with Manufacturing, Regulatory, and Clinical Quality Assurance to foster a culture of quality and compliance throughout the...Full timeWork at officeLocal areaRemote work2 days per week
Allogene Therapeutics
South San Francisco, CA16 days ago - Executive Director GCP Quality Assurance Job Title: Executive Director, Clinical Quality Assurance 3 days onsite in South San Francisco per week Relocation Assistance provided for non-local candidates Job Overview: The Executive Director of Clinical Quality Assurance (...Contract workLocal areaRelocation package
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