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

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

VP, R&D Quality

Key skills