Deputy Director QA
sanofipasteur - Canton, MA

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Description: Member of the Quality Assurance group providing quality and compliance support for all aspects of process development, commercial manufacturing, testing and release of drug substance/drug product.

Support internal and external Quality Systems and Operations, such as facility/equipment, materials, production, laboratory, packaging/labeling and quality. Assure compliance with current GMPs.

  • Manage and coordinate QA staff and/or consultants towards the timely completion of assigned duties and responsibilities.
  • Manage Deviation, CAPA, Change Control. Supplier corrective actions, BPDR and Recall Quality System Elements (QSE)
  • Lead Change Control Board
  • Manage Supplier Quality
  • Lead/conduct/support Audits (internal and external). Travel for vendor/supplier audits, as needed
  • Responsible for Specification Management
  • Responsible for other cross functional activities, as needed
"We are an equal opportunity employer M/F/D/V"

Requirements: Minimum of a BS in Biology, Chemistry, Microbiology or related field.

Must have a minimum of 7-10 years of relevant experience within Quality or Compliance

Must have previous pharmaceutical or biopharmaceutical/vaccine experience

Industry experience with aseptic operations preferred

Experience in maintaining CGMP compliance a must; implementing a plus

The ability to coordinate multiple priorities in a fast paced environment

Solid organization, analytical and problem solving skills

Strong communication skills with the ability to interact with all levels throughout the organization

In addition, demonstrated excellent interpersonal skills and flexibility; demonstrated ability for successful leadership, influence and negotiation a plus

Must have a demonstrated understanding and/or working knowledge of CGMP regulations

Experience managing subordinates and/or projects preferred