Exelixis · 1 day ago
Senior Operations QA Clinical GLP Manager
Alameda, CA
Full-time
Onsite
Senior Level
$165K/yr - $235K/yr
7+ years expExelixis is a biotechnology company focused on developing innovative therapies for cancer. The Senior Operations QA Clinical GLP Manager is responsible for overseeing QA processes and ensuring compliance with GLP and GMP standards in clinical operations, while managing relationships with Contract Manufacturing Organizations.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Represent QA as the QA Partner (Primary Point of Contact) (vendors, CMOs, development collaborators for contracts, validation, change management, GMP and GLP issues)
Develop, implement, and continuously improve QA programs, policies and procedures to ensure GMP and GLP compliance of clinical trial material, and onsite labs
Perform record review, and batch disposition for commercial and clinical trial material, including comprehensive Quality assessment, and review of GLP documents and records
Oversee CMOs and GLP vendors, as applicable: Issue/deviation management, CAPAs with vendors and cross-functional teams to resolve potential product quality issues, rapidly escalate and resolve issues
Generate, review/approve internal and external GMP records (MBR and EBR (master and executed batch records), stability reports/protocols, specifications, deviations, change controls, testing and labeling/packaging records, development/CMC documents submitted to regulatory agencies, GLP documents and records, etc.)
Responsible for developing, tracking and managing periodic management reports, including key GMP and GLP compliance and QA metrics, as applicable
Maintain and report CMO metrics and Operations QA metrics. Evaluate and generate data to support KPIs (Key Performance Indicators)
Identify and rapidly mitigate risk
Independently determines approach to complex compliance issues and rapidly escalates reports findings, with recommendations for resolution, and verifies that appropriate CAPAs were implemented and documented
Contribute to APQR (annual product quality review) as applicable
Support implementation of quality systems, departmental and corporate procedures, to ensure compliance with cGMPs and GLP
Partners with Regulatory Affairs, Clinical Pharmacology, Translational Medicine, PSC, PSC Analytical, and R&D as it pertains to GLP, etc., regarding compliance issues, provides compliance guidance to all audited parties
Maintains knowledge of current regulation requirements; informs stakeholders of potential impact on the organization
Deliver per supply plans, drive results
Qualification
Required
Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of related experience; or
Master's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 7 years of related experience; or
PhD in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 2 years of related experience; or
Equivalent combination of education and experience
A minimum of 8 years of related QA experience or the equivalent combination of experience and education/training
Demonstrated GLP audit conduct and management experience is required
Working knowledge of supporting GLP preparation and submission activities for global regulatory filings
Working knowledge of the end-to-end commercial and clinical manufacturing and quality processes, including US/EU regulations affecting the pharmaceutical industry, and ICH guidelines
Requires a broad range of knowledge and experience with biologic and chemical processes, drug development, analytical testing methods, laboratory practices and tox studies, and understanding of the international regulatory landscape
Small molecule, oral solid form, biologics technical knowledge required
Great attention to detail
Excellent written, verbal and presentation communication skills, able to translate complex concepts across all levels of the organization
Excellent MS Office, Word, Excel and PowerPoint skills
Preferred
Experience in the biotech or pharmaceutical industry, and clinical packaging/labeling activities is preferred
Two years' experience managing Contract Manufacturing Organizations preferred
Five years general experience in biotech/pharmaceutical industry
Experience in development of metrics and continuous improvements is preferred
Benefits
401k plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Sales-based incentive plan
Opportunity to purchase company stock
Receive long-term incentives
15 accrued vacation days in their first year
17 paid holidays including a company-wide winter shutdown in December
Up to 10 sick days throughout the calendar year
Company
Exelixis
Exelixis works is focused on discovering, developing and commercializing therapies for the treatment of cancer and other serious diseases.
1001-5000 employees
H1B Sponsorship
Exelixis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (39)
2024 (25)
2023 (25)
2022 (28)
2021 (29)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
$514MKey Investors
Deerfield
2015-07-23Post Ipo Equity· $135M
2012-02-16Post Ipo Equity· $65M
2010-06-03Post Ipo Debt· $160M
Leadership Team
Michael Morrissey
President and CEO
Christopher Senner
Executive Vice President and CFO
Recent News
2026-01-07
Investor's Business Daily
2025-12-22
Company data provided by crunchbase