VP, R&D Quality

Description

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

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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.