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Sr. Director/VP of Quality

  • Location Watertown, Massachusetts
  • Job-type Permanent
  • Reference BBBH102748

COMPANY:

Clinical-stage Biopharma/Gene Therapy company focusing on rare and serious diseases

LOCATION:

Greater Boston, MA area

TITLE:

Senior Director/VP of Quality

RELOCATION ASSISTANCE:

Not available

ROLE RESPONSIBILITIES:

The Sr. Director/VP of Quality will be responsible for strategy implementation and leadership of Quality functions and execution. This individual will oversee Quality and Compliance oversight for manufacturing, supply chain, Quality Control testing, nonclinical and clinical.

CANDIDATE REQUIREMENTS:

  • Minimum BS degree in a relevant field
  • Minimum 15 years of progressive managerial experience within the quality function in the pharma/biotech industry
  • GMP experience
  • Experience in conducting internal and external audits for GMP, GLP, and GCP compliance as applicable
  • Experience with leading FDA and other agency regulatory inspections a plus
  • Experience with developing a drug through Phase III and commercialization
  • Experience with BLA submissions
  • Hands-on management and leadership experience

If you meet the requirements above and would like to be considered for this position, apply on-line now for immediate consideration and to be contacted with further details