Director, Regulatory Compliance
Vertex Pharmaceuticals
- Boston, MA
- Permanent
- Full-time
- Provides compliance oversight, guidance and direction to all relevant employees, key stakeholders and leadership teams in GRA
- Partners with cross-functional teams to collaborate, negotiate and drive fact- and risk-based decision making
- Supports the Quality System as pertains to GRA, and its applicable subsystems as assigned; oversees quality systems and compliance
- Leads deviation reporting, investigation, and development and closure of corrective actions and effectiveness checks
- Acts as the GRA Lead for regulatory agency, third-party and internal inspections.
- Oversees documentation requests and interactions between GRA and internal Quality groups, addresses findings and adheres to health authority response timelines
- Prioritizes and oversees any remedial measures as a result of a CAPA or other identified compliance issues
- Serves as the regulatory compliance representative on various cross-functional teams to identify and assess risks and develop solutions to mitigate risk
- Oversees the development of key quality metrics related to Regulatory Compliance, tracks and reports out these metrics to RALT
- Collaborates with GRA stakeholders to ensure compliance with policies and regulatory requirements
- As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.
- Advanced and contemporary knowledge and expertise in interpretation of regulations, guidelines, and precedents related to Quality Management Systems and global regulatory and development activities
- Demonstrated experience in a regulatory compliance role
- Results oriented; problem solving capabilities
- Exhibits strong organizational and project management skills necessary to perform complex tasks independently and work on multiple projects simultaneously
- Strong interpersonal and communication skills, and the ability to effectively influence others internally/externally including colleagues at all levels of the company, including but not limited to GRA, Manufacturing, Clinical, Quality Assurance, Legal, and Information Technology
- Experience with Health Authority inspections/audits and the development and implementation of compliance corrective action plans
- Bachelor's degree in a scientific or allied health field
- Typically requires 10 years of experience in relevant regulatory compliance work or the equivalent combination of education and experience