Associate QA Operations Director- Computer Systems and Data Integrity
Exelixis
5 hours ago
Remote friendly (Alameda, CA)
United States
$156,000 - $222,000 USD yearly
Operations
Responsibilities:
- Drive a risk-based, comprehensive Data Integrity (DI) program implementation meeting cGxP regulations.
- Provide Computer System Validation (CSV) oversight by setting/maintaining DI/CSV strategy, QA oversight, and updating policies/procedures based on the regulatory landscape.
- Establish cross-functional metrics for compliance and continuous improvement; assess, resolve, and/or escalate CSV/DI issues and associated risks.
- Develop a risk-based strategy across the GxP landscape to identify and manage issues/risks and ensure ongoing compliance to global DI standards.
- Review and approve validation deliverables (e.g., URS, FS, IQ/OQ/PQ).
- Monitor emerging health authority requirements for GxP computerized systems and data creation/handling; revise procedures accordingly.
- Identify KPIs, define success criteria, and deliver continuous improvement.
- 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.
- Maintain compliance with Title 21 CFR Part 11 for systems used to generate, modify, maintain, archive, retrieve, or transmit GxP data.
- Provide guidance on global health authority regulations related to computer system requirements.
- Provide QA support for Exelixis GxP computer systems and platforms.
- Establish stakeholder relationships to ensure timely documentation, escalation, and resolution of quality issues.
Qualifications:
- BS/BA degree (Biology, Computer Science, Education/Learning & Development, Sciences, or related) with 11 years related experience; or MS/MA with 9 years; or equivalent education and experience.
- Significant management experience in pharmaceutical/biotech required.
- Oncology experience required.
- Experience in Portfolio, Project and/or Alliance Management.
- Experience with data querying/management tools including SAS or SQL.
Knowledge/Skills:
- Thorough knowledge of drug development, GxP global regulatory requirements, and DI/CSV regulations.
- Ability to manage multiple priorities; evaluate data for weak signals/blind spots and escalate cumulative risks.
- Ability to lead through change and drive results.
- Excellent written, verbal, and presentation communication skills; translate complex concepts across all levels.
- Strong collaboration with cross-functional teams.
- Ability to interpret/analyze data and provide effective technical solutions.
Benefits (as stated):
- Base pay range: $156,000–$222,000 annually.
- 401k with generous company contributions; group medical/dental/vision; life/disability; flexible spending accounts.
- Discretionary annual bonus (sales-based incentives for field sales).
- Company stock purchase; long-term incentives; 15 vacation days (first year); 17 paid holidays (incl. winter shutdown in December); up to 10 sick days.
Travel:
- 5–10% as required.
- Drive a risk-based, comprehensive Data Integrity (DI) program implementation meeting cGxP regulations.
- Provide Computer System Validation (CSV) oversight by setting/maintaining DI/CSV strategy, QA oversight, and updating policies/procedures based on the regulatory landscape.
- Establish cross-functional metrics for compliance and continuous improvement; assess, resolve, and/or escalate CSV/DI issues and associated risks.
- Develop a risk-based strategy across the GxP landscape to identify and manage issues/risks and ensure ongoing compliance to global DI standards.
- Review and approve validation deliverables (e.g., URS, FS, IQ/OQ/PQ).
- Monitor emerging health authority requirements for GxP computerized systems and data creation/handling; revise procedures accordingly.
- Identify KPIs, define success criteria, and deliver continuous improvement.
- 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.
- Maintain compliance with Title 21 CFR Part 11 for systems used to generate, modify, maintain, archive, retrieve, or transmit GxP data.
- Provide guidance on global health authority regulations related to computer system requirements.
- Provide QA support for Exelixis GxP computer systems and platforms.
- Establish stakeholder relationships to ensure timely documentation, escalation, and resolution of quality issues.
Qualifications:
- BS/BA degree (Biology, Computer Science, Education/Learning & Development, Sciences, or related) with 11 years related experience; or MS/MA with 9 years; or equivalent education and experience.
- Significant management experience in pharmaceutical/biotech required.
- Oncology experience required.
- Experience in Portfolio, Project and/or Alliance Management.
- Experience with data querying/management tools including SAS or SQL.
Knowledge/Skills:
- Thorough knowledge of drug development, GxP global regulatory requirements, and DI/CSV regulations.
- Ability to manage multiple priorities; evaluate data for weak signals/blind spots and escalate cumulative risks.
- Ability to lead through change and drive results.
- Excellent written, verbal, and presentation communication skills; translate complex concepts across all levels.
- Strong collaboration with cross-functional teams.
- Ability to interpret/analyze data and provide effective technical solutions.
Benefits (as stated):
- Base pay range: $156,000–$222,000 annually.
- 401k with generous company contributions; group medical/dental/vision; life/disability; flexible spending accounts.
- Discretionary annual bonus (sales-based incentives for field sales).
- Company stock purchase; long-term incentives; 15 vacation days (first year); 17 paid holidays (incl. winter shutdown in December); up to 10 sick days.
Travel:
- 5–10% as required.