Director, Regulatory Compliance

Vertex Pharmaceuticals

  • Boston, MA
  • Permanent
  • Full-time
  • 2 months ago
Job DescriptionGeneral Summary:The Director, Regulatory Compliance is responsible for ensuring that Global Regulatory Affairs (GRA) adheres to Vertex’s compliance framework, and that GRA requirements are embedded within the Quality Framework. This role provides compliance oversight, guidance, and direction to all GRA relevant functions, key stakeholders and leadership teams. This role investigates departmental deviations, and oversees internal compliance reporting, metrics and prioritization of risk based deliverables.Key Duties and Responsibilities:
  • 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.
Knowledge and Skills:
  • 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
Education and Experience:
  • 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
We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:1. Hybrid and work remotely up to two days per week; or select2. On-Site and work 5 days per week with ad hoc flexibility.#LI-EE1 #LI-HybridCompany InformationVertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.

Vertex Pharmaceuticals