Exelixis · 1 day ago
Associate GCP/GLP QA Director
Alameda, CA
Full-time
Onsite
Director/Executive
$154K/yr - $217K/yr
9+ years expExelixis is a company focused on driving consistency in QA systems and processes for the Clinical QA team. The Associate GCP/GLP QA Director will oversee quality assurance activities related to clinical trials, ensuring compliance with regulations and standards while collaborating with various departments to enhance quality systems.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Responsible for designing and coordinating a comprehensive view and aligning standards on Quality systems across Clinical Quality Assurance
Assesses current state, identifies gaps, develops an action plan, implements improvements, and monitors the Quality Systems and internal processes related to GCP QA activities
Develops, tracks, and manages periodic management reports focused on track and trend data for key Clinical and QA metrics driving the quality health of the GCP activities
Reviews and approves Deviations, and Corrective and Preventive Actions (CAPAs)
Partners with other groups including Regulatory Affairs, Clinical Operations, Translational Medicine, regarding compliance issues and provides compliance guidance
Maintains knowledge of current Health Authority regulations and standards and informs Clinical Development stakeholders of potential impact on the organization
Represents CQA in internal presentations on quality issues, initiatives, and projects
Identifies issues and risks and proposes options and solutions, escalating risks in a timely manner
Participates in identifying and implementing process and system improvements
Qualification
Required
Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 11 years of relevant experience; or
Master's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of relevant experience; or
PhD degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 5 years of relevant experience; or
Equivalent combination of education and experience
Minimum of 10 years relevant experience in pharmaceutical and biotech industries
Experience in Good Clinical Practices highly desired
Demonstrated experience in Quality Systems including critical analysis of impact and continuous improvement processes
Strong understanding of Quality Risk Management
Experience using standard MS Office
Understanding of the drug development process, particularly related to QA oversight of clinical trials
Experience in assisting in the development of business strategies, metrics, and continuous improvements
Working knowledge of Health Authority rules and regulations
Proven ability to manage Quality Systems, assuring completeness and acceptability as defined for GCP
Ability to apply Quality Risk Management in a variety of situations across Quality Systems
Ability to influence others as part of a collaborative team and negotiate effective solutions
Strong interpersonal and social skills
Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results
Detail-oriented in execution of tasks and processes
Implements technical solutions within quality requirements to complex problems
Excellent verbal and written communication skills
Exercises judgment within defined procedures and practices to determine appropriate action
Provides insight and analysis of situations or data requires a review of a variety of factors
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