In an virtual company environment, the Executive Director, Quality Assurance is responsible for the strategy, implementation & leadership of the Quality function at Boston Biomedical and is accountable for the execution and administration of the GXP Quality System pertaining to GMP, GLP and GCP and relevant ICH, US and EU regulations.
Vice President and Head of Regulatory Affairs and Quality
- Ensures overall Quality and Compliance oversight for manufacturing, nonclinical, clinical & supply chain activities.
- Establishes and maintains phase-appropriate Quality Management Systems
- Ensures appropriate Quality oversight of external vendors (CMOs, CROs, etc.)
- Oversight of Boston Biomedical’s Internal Quality Systems
- Plans and oversees day-to-day activities of the Quality function including management of consultants/auditors as needed, to ensure project and business needs are met.
- Develops and oversees appropriate Quality metrics and report on the state of Boston Biomedical’s compliance to senior management.
- Ensures integration with DSP’s Quality Systems.
- Leads preparations for and management of any Regulatory Agency inspections.
- Provides leadership and mentorship of the Quality team.
- Coordinates with supply chain and IT interfaces.
- Accomplishes tasks from a virtual company perspective.
Professional Experience / Qualifications:
- BS in Chemistry, Pharmacy, Biology or a related pharmaceutical science, MS preferred.
- 15+ years of progressive managerial experience within the Quality function of a pharmaceutical company. Experience leading a Quality function is required.
- Extensive knowledge and experience in GXP and QA principles, practices & industry standards
- Experience with drug development programs, from early-stage through to commercial.
- Experience with using risk-based principles & decision making to ensure compliance at all stages of development.
- Experience with a virtual company environment.
Job Location: Cambridge, MA
Please send resumes to email@example.com