VP, R&D Quality & Medical Governance
VP, R&D Quality & Medical Governance
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
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.
- 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
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
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