Exelixis · 2 days ago
Associate Compliance QA Director - Vendors
Alameda, CA
Full-time
Onsite
Director/Executive
$154K/yr - $217K/yr
9+ years expExelixis is a biotechnology company focused on developing innovative cancer therapies. The Associate Compliance QA Director - Vendors is responsible for QA oversight of the vendor management program, ensuring compliance and quality through risk management and effective vendor performance monitoring.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Create, maintain and continously improve an end-to-end vendor management lifecycle framework that defines all aspects of a lifecycle program, and provides QA oversight using Quality Risk Management (QRM)
Provide cross-functioanl vendor management QA oversight where required
Author and update QA documents as necessary
Using QRM, identify, mitigate and resolve issues and risks associated with vendor management, escalating issues timely
Support internal and external stakeholders in monitoring vendor performance
Define and maintain the tracking and trending of quality metrics related to vendor management oversight
Apply applicable Health Authority regulations and guidance related to vendor management oversight. Review new regulations and guidance on a frequent basis to assure compliance, and ensure information is escalated across the organization
Provide expertise, providing options and opportunities to build Quality into the system and drive value to the overall business
Drive for results, and propose feasible solutions that will ensure timely delivery on core company objectives
Qualification
Required
BS/ BA preferably in the life sciences or STEM disciplines and a minimum of 11 years of related experience; or
MS/M.Sc. preferably in the life sciences or STEM disciplines and a minimum of 9 years of related experience; or
PhD preferably in the life sciences or STEM disciplines and a minimum of 5 years of related experience; or
Equivalent combination of education and experience
Minimum of 10 years' experience in biotech, pharmaceutical or related industry or the equivalent combination of education/training and experience
This position requires a broad range of knowledge and experience with GxP processes related to managing vendors, partners, and suppliers
Requires broad experience with GxP processes related to vendor management, and strong partnerships with internal and external partners to resolve issues for continuous improvement, and ability to build user friendly systems right sized for the organization to pragmatically apply applicable Health Authority rules and regulations and international standards and guidelines
Demonstrated knowledge of GxP Health Authority Regulations and Quality Systems
Proven organizational and management skills to build systems and coordinate multi-discipline project groups
Demonstrated ability to present to a variety of audiences, including HA inspectors, Partners and Senior Management
Experience with presenting or defending departmental functions in audits or regulatory inspections
Deep knowledge and understanding of clinical and commercial processes and associated regulations related to GxP
Excellent written, verbal and presentation communication skills, able to translate complex concepts across all levels of the organization
Strong collaboration skills and demonstrated ability to lead through change and identify opportunities driving positive business outcomes
Excellent organizational agility, gets results while strengthening internal and external relationships
Makes timely decisions and escalates issues and risks supported by QRM principles
Ability to influence decision makers utilizing sound problem solving skills to recommend options and implement feasible solutions
Highly skilled in the ability to work with ambiguity and complexity; can continuously modify options and solutions across all levels of the organization
Ability to deliver on company core objectives and principles, and achieve goals with measurable impact and outcomes
Preferred
Knowledge of biologics and chemical processes 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
The Motley Fool
2026-01-09
2026-01-08
Company data provided by crunchbase