Hiring company: Gilead
Reporting to the SVP of Global Regulatory Affairs, Patient Safety and Quality, the VP of R&D Quality and Medical Governance will be responsible for the vision, recommendations and execution of the worldwide R&D and Medical Affairs quality strategy as an independent and objective function for all investigational and marketed products across Gilead’s therapeutic areas – Virology, Oncology, and Inflammation. The VP will lead a global team and leverage their experience to build and manage a thriving global department in a cross-functional and multi-cultural environment. This role will provide quality management oversight for all regions in line with the goals of the R&D organization, including Medical Affairs. The VP will collaborate closely with stakeholders and be a critical key decision maker in a rapidly developing environment to ensure that the company remains at the forefront of all new regulations.
Specific Responsibilities
Provide strategic leadership to the global R&D Quality & Medical Governance organization including, but not limited to, clinical compliance and pharmacovigilance, electronic systems and laboratory compliance, and quality documents and training administration.
Provide oversight to Medical Affairs quality and governance and collaborate with Gilead’s Chief Compliance Officer on healthcare compliance execution.
Promote a culture of R&D compliance across the regions with the highest levels of integrity to meet all global standards
Represent Gilead and the R&D Quality and Medical Governance organization in meetings with regulatory authorities and other stakeholders around the world
Ensure that appropriate quality measures and controls are in place to align with and support the requirements of industry laws, rules, regulations and guidance documents
Ensure ongoing compliance in R&D operations and prepare for regulatory agency inspections and internal audits around the world
Oversee the management of all R&D quality issues, including regulatory compliance with CAPAs, transaction monitoring, quality control, continuing education/tracking and data privacy (in collaboration with the Privacy, Cybersecurity and Information Governance team)
With respect to R&D quality, lead risk assessments and implement compliance monitoring and testing program across R&D
Set the strategic direction for the risk management and engagement of R&D quality for third-party vendors
Lead the approach for employee training sessions on internal GxP policies and procedures
Collaborate with key stakeholders for R&D quality audit programs to develop audit strategy in order to identify organizational risks
Provide strategic vision for inspection management and responses, working closely with global regulatory agencies
Responsible for continuous optimization of procedural documents and associated training
Drive integrated quality annual reviews with Gilead senior management including the SVP of Quality Assurance with the manufacturing organization
Qualifications and Skills
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
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