Site Reliability Engineer improving operational characteristics and collaborating with feature teams for service objectives. Leading automation and reliability initiatives while coaching colleagues.
About the role
- VP of R&D Quality leading global compliance for pharmaceutical products across Gilead's therapeutic areas. Collaborating with stakeholders for strategic oversight and regulatory alignment.
Responsibilities
- Reporting to the SVP of Global Regulatory Affairs, Patient Safety and Quality
- Responsible for the vision, recommendations and execution of the worldwide R&D and Medical Affairs quality strategy
- Lead a global team and leverage their experience to build and manage a thriving global department
- Provide quality management oversight for all regions in line with the goals of the R&D organization
- Collaborate closely with stakeholders and be a key decision maker in a rapidly developing environment
- Promote a culture of GxP quality across R&D with the highest levels of integrity
- Ensure appropriate quality measures and controls are in place
- Enable efficiency and continuous improvement through process capabilities
- Prepare for regulatory agency inspections and internal audits
- Oversee the management of all R&D quality issues
- Lead risk assessments and implement compliance monitoring across R&D
- Collaborate with key stakeholders for audit programs
Requirements
- 15+ years of comprehensive regulatory compliance leadership experience in the pharmaceutical industry
- Bachelor’s degree required; advanced degree (Master’s or PhD) or healthcare specialty (MD or PharmD) preferred
- Proven ability to lead, influence, and demonstrate cross-functional collaboration to ensure R&D quality
- Strong understanding of the required elements of a quality program on a global scale, including health authority rules and regulations, industry guidance, and other issues impacting the development of pharmaceutical products
- Experience identifying innovative technologies that scale across the enterprise to meet business needs
- Demonstrated ability to collaborate with all levels of management; strong influencing skills and business acumen
- Proven experience working in a highly matrixed, complex, and fast-paced rapidly changing global environment
- Experience driving out inefficiencies at scale
- Extensive history working with regulatory health authorities and complying with required regulatory guidelines including inspection readiness and follow-up
- Demonstrated ability to build, mentor, and develop a high performing global leadership team
- Proven skills at Quality risk-based decision making
Benefits
- Equal employment opportunities
- Fostering an inclusive work environment
Job title
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