Director, R&D Quality
Gilead Sciences
5 hours ago
Remote friendly (San Francisco Bay Area)
United States
Operations
Director, R&D Diagnostics Quality
Key Responsibilities
- Partner with Research and Development Leadership to evaluate the current state of quality and potential risk for IVD use within Precision Medicine studies.
- Serve as the resident R&D compliance expert for diagnostic R&D programs, spanning clinical trials with investigational devices across therapeutic areas (may also provide oversight more broadly, including combination products and laboratory quality).
- Ensure appropriate quality oversight for precision medicine programs, including partners and service providers.
- Lead development of diagnostic quality management strategies to ensure compliance with the evolving regulatory landscape.
- Advance understanding of US/EU device regulation to support R&D programs and the regulatory framework to ensure data integrity and patient safety.
- Develop and monitor KQIs for critical-to-quality IVD areas needing improvement and/or key risks reportable through quality management review.
- Lead quality investigations, RCA, CAPA oversight, and remediation planning for device-related issues; support device-centric audits, regulatory agency inspections, and risk assessments.
- Act as a strategic partner to R&D functions (Diagnostics, Regulatory Affairs, Patient Safety, Clinical Operations), advising on diagnostic quality risks and mitigations.
Minimum Required Education and Years of Experience
- PharmD/PhD with 8+ years relevant experience OR
- MA/MS/MBA with 10+ years relevant experience OR
- BA/BS with 12+ years relevant experience.
Preferred Qualifications, Knowledge & Other Requirements
- Advanced degree in life sciences or related field; extensive biopharma experience in quality/compliance or related field.
- Experience in medical device quality, including prior diagnostic quality role.
- Deep understanding of medical devices in clinical trials and regulatory submissions (e.g., IDEs, NDA, 510(k)).
- Understanding of FDA + global medical device regulations/guidance and how to apply them in R&D.
- Recognized expert in regulations including FDA 21 CFR Part 820/812/4, ISO 13485, ISO 14971, EU MDR/IVDR, ICH.
- Track record in medical device development/launch, inspection readiness, QMS design, and resolution of compliance issues.
- Strong presentation, communication, and executive engagement; health authority interaction experience (FDA, EMA, MHRA, Notified Bodies) is a plus.
- Ability to lead cross-functional programs and influence without authority in matrixed environments.
- Certifications (ASQ, Six Sigma Black Belt, RAPS medical device certifications such as RAC-Devices; RCC-MDR or RCC-IVDR) are a plus.
- Expert knowledge of GxP regulations for medical devices and diagnostics/CDx; good understanding of CAP/CLIA/ICH requirements.
- Sponsor experience in a quality role supporting GxP clinical builds involving investigational devices (highly preferred).
- Laboratory quality experience (GLP/GCLP) (preferred).
- Strong leadership, interpersonal, organizational, negotiation, and conflict-resolution skills.
- Ability to travel when needed.
People Leader Accountabilities
- Create Inclusion.
- Develop Talent (coach and enable feedback/growth).
- Empower Teams (align goals, purpose, and objectives; remove barriers).
Compensation and Benefits (as stated)
- Salary range: $210,375.00 - $272,250.00.
- May be eligible for discretionary bonus, stock-based long-term incentives, paid time off, and benefits including company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.
Key Responsibilities
- Partner with Research and Development Leadership to evaluate the current state of quality and potential risk for IVD use within Precision Medicine studies.
- Serve as the resident R&D compliance expert for diagnostic R&D programs, spanning clinical trials with investigational devices across therapeutic areas (may also provide oversight more broadly, including combination products and laboratory quality).
- Ensure appropriate quality oversight for precision medicine programs, including partners and service providers.
- Lead development of diagnostic quality management strategies to ensure compliance with the evolving regulatory landscape.
- Advance understanding of US/EU device regulation to support R&D programs and the regulatory framework to ensure data integrity and patient safety.
- Develop and monitor KQIs for critical-to-quality IVD areas needing improvement and/or key risks reportable through quality management review.
- Lead quality investigations, RCA, CAPA oversight, and remediation planning for device-related issues; support device-centric audits, regulatory agency inspections, and risk assessments.
- Act as a strategic partner to R&D functions (Diagnostics, Regulatory Affairs, Patient Safety, Clinical Operations), advising on diagnostic quality risks and mitigations.
Minimum Required Education and Years of Experience
- PharmD/PhD with 8+ years relevant experience OR
- MA/MS/MBA with 10+ years relevant experience OR
- BA/BS with 12+ years relevant experience.
Preferred Qualifications, Knowledge & Other Requirements
- Advanced degree in life sciences or related field; extensive biopharma experience in quality/compliance or related field.
- Experience in medical device quality, including prior diagnostic quality role.
- Deep understanding of medical devices in clinical trials and regulatory submissions (e.g., IDEs, NDA, 510(k)).
- Understanding of FDA + global medical device regulations/guidance and how to apply them in R&D.
- Recognized expert in regulations including FDA 21 CFR Part 820/812/4, ISO 13485, ISO 14971, EU MDR/IVDR, ICH.
- Track record in medical device development/launch, inspection readiness, QMS design, and resolution of compliance issues.
- Strong presentation, communication, and executive engagement; health authority interaction experience (FDA, EMA, MHRA, Notified Bodies) is a plus.
- Ability to lead cross-functional programs and influence without authority in matrixed environments.
- Certifications (ASQ, Six Sigma Black Belt, RAPS medical device certifications such as RAC-Devices; RCC-MDR or RCC-IVDR) are a plus.
- Expert knowledge of GxP regulations for medical devices and diagnostics/CDx; good understanding of CAP/CLIA/ICH requirements.
- Sponsor experience in a quality role supporting GxP clinical builds involving investigational devices (highly preferred).
- Laboratory quality experience (GLP/GCLP) (preferred).
- Strong leadership, interpersonal, organizational, negotiation, and conflict-resolution skills.
- Ability to travel when needed.
People Leader Accountabilities
- Create Inclusion.
- Develop Talent (coach and enable feedback/growth).
- Empower Teams (align goals, purpose, and objectives; remove barriers).
Compensation and Benefits (as stated)
- Salary range: $210,375.00 - $272,250.00.
- May be eligible for discretionary bonus, stock-based long-term incentives, paid time off, and benefits including company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.