Exelixis · 2 days ago
Associate QA Operations Director- Computer Systems and Data Integrity
Alameda, CA
Full-time
Onsite
Director/Executive
$156K/yr - $222K/yr
9+ years expExelixis is a company focused on advancing cancer care, and they are seeking an Associate Director for Computer Systems and Data Integrity to oversee the implementation of a risk-based DI program and ensure compliance with cGxP regulations. The role involves generating strategies, reviewing validation deliverables, and collaborating with stakeholders to resolve quality issues.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Responsible for generating a risk-based strategy across the GxP landscape that identifies and manages issues and risks while driving continuous improvement to ensure continuous compliance to global DI standards and aligning with key stakeholders
Reviews and approves validation deliverables (URS, FS, IQ/OQ/PQ, etc.)
Monitors emerging regulatory health authority requirements for GxP computerized systems, process controls, and compliance for data creation and handling, and ensures that procedures are revised accordingly
Team player and driver, identifies KPIs, sets metrics and success criteria
Identifies, mitigates, escalates and resolves issues and risks
Authors and review CSV, DI policies, procedures, lifecycle documents
SME for Health Authority inspections and audits
Delivers CSV/DI training as required
Responsible for establishing and maintaining a program compliant with Title 21 CFR Part 11 for systems used to generate, modify, maintain, archive, retrieve, or transmit GxP data
Understands global Health Authority regulations and guidance as it pertains to computer system requirements and provide guidance
Provides QA support for all Exelixis GxP Computer systems and platforms
Establishes strong collaborative relationships with internal and external stakeholders to ensure timely documentation, escalation and resolution of quality issues
Qualification
Required
BS/BA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 11 years of related experience; or
MS/MA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 9 years of related experience; or
Equivalent combination of education and applicable experience
Significant management experience within the pharmaceutical and biotech industries required
Oncology experience is required
Experience in Portfolio, Project and/or Alliance Management
Experience using standard data querying and management tools including SAS or SQL
Thorough knowledge and understanding of drug development process, GxP Global Regulatory Requirements and regulations related to DI/CSV
Proven ability to manage multiple competing priorities, evaluate data to detect weak signals, blind spots and rapidly escalate cumulative risks
Demonstrated ability to lead through change by engaging others, assessing unforeseen situations, continuously learning to achieve a goal, and drive for results
Excellent written, verbal and presentation communication skills, able to translate and communicate complex concepts across all levels of the organization
Successfully engages and collaborates effectively with cross functional teams
Proven ability to interpret and analyze data, provide feasible and effective technical solutions
Applies strong analytical thinking to develop technical and/or business solutions to complex problems
Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results
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
Investor's Business Daily
2025-12-22
2025-12-13
2025-12-12
Company data provided by crunchbase