Executive Director, GCP Quality Assurance
Exelixis
3 months ago
On-site
Alameda, CA
Clinical Research and Development
Responsibilities:
- Define and implement an end-to-end GCP/GVP QA strategy and direction.
- Establish and maintain the GCP/GVP Inspection Readiness program; support development/revision of functional and cross-functional policies and procedures.
- Lead and develop a team of GCP/GVP QA professionals; oversee and coach team members through touchpoints and meetings.
- Coordinate cross-functional GCP/GVP Inspection Readiness Governance Council (IRGC).
- Lead inspection readiness initiatives internally; partner with clinical study teams and CROs on inspection preparation at clinical sites.
- Collaborate with Compliance QA on GCP/GVP mock inspections, internal audits, and clinical site audits.
- Manage regulatory health authority sponsor inspections (moderator role); respond to first-level questions, triage to SMEs, manage complex questions, and defend company processes.
- Partner with cross-functional stakeholders to identify GCP/GVP issues and risks; maintain risk log/scorecard and metrics for risk-based decisions.
- Support Quality Risk Management (QRM) to identify, track, and mitigate GCP/GVP risks; trend metrics to inform decisions.
- Manage patient safety and clinical data integrity/reliability risks through QA oversight.
- Review/approve non-clinical and clinical trial documents (e.g., protocols/amendments, risk management plans) and regulatory submissions.
- Assess new regulations/guidance for required process/training updates.
- Partner with key stakeholders (including Clinical Operations) to define QA oversight of CROs and critical vendors.
- Interpret and apply ICH E6 (R3) and GCP/GVP regulatory guidelines.
- Provide leadership, technical expertise, guidance, coaching, and development to the QA team.
Supervisory responsibilities:
- Lead a team of GCP/GVP quality professionals.
- Lead the cross-functional IRGC team.
Qualifications/Requirements:
- BS/B.Sc (life sciences/STEM) + minimum 18 years related experience OR MS/M.Sc + 16 years OR PhD + 15 years OR equivalent education/experience.
- Minimum 22 years’ experience in biotech/pharmaceutical/related industry.
- Minimum 10 years of people management (direct or indirect).
- Demonstrated knowledge of GCP, GVP, and Quality Systems.
Preferred skills/experience:
- Experienced in hosting regulatory inspections and defending functions in internal/business partner audits and clinical site audits.
- International/global experience.
- Auditing experience.
- Solid understanding of peer best practices for clinical trial execution.
Skills:
- Deep knowledge of GCP/GVP and global regulatory requirements (GxP).
- Strong communication (written/oral/presentation) and ability to translate complex concepts.
- Ability to influence decision makers; strong problem-solving.
- Analytical thinking for complex technical/business solutions; drives for results.
- Skilled leader of inspection readiness working groups.
- Strong organizational agility and project management.
- Ability to work with ambiguity/complexity and make timely quality-focused decisions.
- Travel as required (20–30%).
Benefits:
- 401k with generous company contributions; group medical/dental/vision; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales); opportunity to purchase company stock; long-term incentives.
- 15 vacation days (first year), 17 paid holidays (including winter shutdown in December), up to 10 sick days.
Education/Experience and work arrangement:
- Onsite at Alameda, CA headquarters.
Application instructions:
- Not provided in the text.
- Define and implement an end-to-end GCP/GVP QA strategy and direction.
- Establish and maintain the GCP/GVP Inspection Readiness program; support development/revision of functional and cross-functional policies and procedures.
- Lead and develop a team of GCP/GVP QA professionals; oversee and coach team members through touchpoints and meetings.
- Coordinate cross-functional GCP/GVP Inspection Readiness Governance Council (IRGC).
- Lead inspection readiness initiatives internally; partner with clinical study teams and CROs on inspection preparation at clinical sites.
- Collaborate with Compliance QA on GCP/GVP mock inspections, internal audits, and clinical site audits.
- Manage regulatory health authority sponsor inspections (moderator role); respond to first-level questions, triage to SMEs, manage complex questions, and defend company processes.
- Partner with cross-functional stakeholders to identify GCP/GVP issues and risks; maintain risk log/scorecard and metrics for risk-based decisions.
- Support Quality Risk Management (QRM) to identify, track, and mitigate GCP/GVP risks; trend metrics to inform decisions.
- Manage patient safety and clinical data integrity/reliability risks through QA oversight.
- Review/approve non-clinical and clinical trial documents (e.g., protocols/amendments, risk management plans) and regulatory submissions.
- Assess new regulations/guidance for required process/training updates.
- Partner with key stakeholders (including Clinical Operations) to define QA oversight of CROs and critical vendors.
- Interpret and apply ICH E6 (R3) and GCP/GVP regulatory guidelines.
- Provide leadership, technical expertise, guidance, coaching, and development to the QA team.
Supervisory responsibilities:
- Lead a team of GCP/GVP quality professionals.
- Lead the cross-functional IRGC team.
Qualifications/Requirements:
- BS/B.Sc (life sciences/STEM) + minimum 18 years related experience OR MS/M.Sc + 16 years OR PhD + 15 years OR equivalent education/experience.
- Minimum 22 years’ experience in biotech/pharmaceutical/related industry.
- Minimum 10 years of people management (direct or indirect).
- Demonstrated knowledge of GCP, GVP, and Quality Systems.
Preferred skills/experience:
- Experienced in hosting regulatory inspections and defending functions in internal/business partner audits and clinical site audits.
- International/global experience.
- Auditing experience.
- Solid understanding of peer best practices for clinical trial execution.
Skills:
- Deep knowledge of GCP/GVP and global regulatory requirements (GxP).
- Strong communication (written/oral/presentation) and ability to translate complex concepts.
- Ability to influence decision makers; strong problem-solving.
- Analytical thinking for complex technical/business solutions; drives for results.
- Skilled leader of inspection readiness working groups.
- Strong organizational agility and project management.
- Ability to work with ambiguity/complexity and make timely quality-focused decisions.
- Travel as required (20–30%).
Benefits:
- 401k with generous company contributions; group medical/dental/vision; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive for field sales); opportunity to purchase company stock; long-term incentives.
- 15 vacation days (first year), 17 paid holidays (including winter shutdown in December), up to 10 sick days.
Education/Experience and work arrangement:
- Onsite at Alameda, CA headquarters.
Application instructions:
- Not provided in the text.