VP, R&D Quality

Arbeitsbeschreibung

Reporting to the SVP of Global Regulatory Affairs, Patient Safety and Quality, the VP of R&D Quality 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 GxP quality across R&D 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

• Enable efficiency and continuous improvement through the build-out of process capabilities, including a Global Process Owner network, process maps and end-to-end visualization of R&D activities.

• 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 R&D Quality management review program to assure visibility and drive continuous improvement.

• Serve on Enterprise Quality Council, representing R&D, to enable end-to-end GxP oversight and contribute to integrated quality reviews with Gilead executive 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