Associate QA Operations Director- Computer Systems and Data Integrity

Role Summary

This Associate Director, Computer Systems and Data Integrity is accountable for driving a risk-based, comprehensive DI program aligned with cGxP regulations, and oversees Computer System Validation (CSV) by setting strategy, QA governance, and policy updates. They collaborate cross-functionally to measure compliance and drive continuous improvement, and to assess, escalate and resolve CSV/DI issues and risks. They represent QA as the primary partner for Exelixis stakeholders, providing QA support in strategic and decision forums and ensuring delivery on core goals and pipeline deliverables.

Responsibilities

• Generate a risk-based strategy across the GxP landscape to identify and manage issues and risks while driving continuous improvement to ensure ongoing compliance with global DI standards and alignment with key stakeholders.
• Review and approve validation deliverables (URS, FS, IQ/OQ/PQ, etc.).
• Monitor emerging regulatory health authority requirements for GxP computerized systems, process controls, and data handling, and revise procedures accordingly.
• Act as a team player and driver, identify KPIs, and set metrics and success criteria.
• Identify, mitigate, escalate and resolve issues and risks.
• Author and review CSV, DI policies, procedures, and lifecycle documents.
• Serve as SME for Health Authority inspections and audits.
• Deliver CSV/DI training as required.
• Establish and maintain a program compliant with 21 CFR Part 11 for systems generating, modifying, maintaining, archiving, retrieving, or transmitting GxP data.
• Understand global Health Authority regulations and provide guidance related to computer system requirements.
• Provide QA support for all Exelixis GxP computer systems and platforms.
• Establish strong collaborative relationships with internal and external stakeholders to ensure timely documentation, escalation and resolution of quality issues.

Qualifications

• BS/BA in Biology, Computer Science, Education, Learning & Development, Sciences, or related field with 11 years of related experience; or
• MS/MA in Biology, Computer Science, Education, Learning & Development, Sciences, or related field with 9 years of related experience; or
• Equivalent combination of education and applicable experience.

• Significant management experience within the pharmaceutical and biotech industries.
• Oncology experience required.
• Experience in Portfolio, Project and/or Alliance Management.
• Experience using standard data querying and management tools including SAS or SQL.

Knowledge, Skills and Abilities

• Thorough knowledge of the drug development process, GxP Global Regulatory Requirements and regulations related to DI/CSV.
• Ability to manage multiple priorities, evaluate data to detect weak signals, and rapidly escalate cumulative risks.
• Ability to lead through change by engaging others and driving for results.
• Excellent written, verbal and presentation communication skills; able to translate complex concepts across all levels of the organization.
• Proven collaboration with cross-functional teams.
• Ability to interpret and analyze data and develop feasible technical solutions.
• Analytical thinking to develop technical and business solutions to complex problems.
• Identify and implement methods, techniques, procedures and evaluation criteria to achieve results.

Education

• As listed in Qualifications above.

Additional Requirements

• Travel as required: 5-10% of time.