Director, GMP QA

  • Location:Cambridge, MA
  • Department:Quality
  • Type:Full Time
  • Min. Experience:Senior Manager/Supervisor

 

Covid- 19 Mandatory Vaccination Requirement

Throughout the pandemic, we’ve done all that we can to keep our employees safe, and the employees coming in have been careful to take precautions to reduce the risk of bringing Covid into our work environment. As we reopen our office, we’re mindful that the pandemic is not yet over, and young children are not yet vaccinated. We are committed to continuing to protect our team and keep our office safe.  Vaccination has proven to be the best thing you can do to protect yourself, your family, your colleagues and your community. Since we are striving for a 100% vaccinated workplace (including employees, contractors, vendors and guests), all NEW HIRES will be required to be fully vaccinated, and to present proof of their Covid-19 vaccination to our HR team as part of our on-boarding process.

 

 

RESPONSIBILITIES

  • Lead the GMP quality team in the development of GMP quality strategies to support the development, manufacturing, testing and disposition of early phase through commercial materials.
  • Establish and maintain policies and procedures for quality function as well as provide guidance/review within these functional areas
  • Support internal and external audit plans Plan, execute and report audits, as necessary, and work with staff to ensure proposed corrective actions received from the auditees are appropriate
  • Provide quality strategy and oversight for external manufacturing, service providers and testing laboratories
  • Provide quality strategy and oversight for Surface stability and specification programs
  • Help prepare Surface employees for regulatory inspections of Surface and/or vendors.
  • Help host regulatory inspections, as necessary, and provide input and review of responses to regulatory agency questions resulting from these inspections
  • Contribute to the continuing development of a quality culture
  • Build and foster cross-functional partnerships throughout the organization
  • Collaborate with Regulatory Affairs, CMC and Quality to complete review of regulatory filings and regulatory communications.
  • Oversee the review, approval and disposition of materials and product
  • Independently manage delegated quality projects
  • Escalation of Quality issues to the Head of Quality, when appropriate

 

EDUCATION AND EXPERIENCE: 

  • BS, MS and a minimum of 12 years’ experience, respectively in biotech Pharma, or clinical research organization
  • Experience in early phase through commercial product development
  • At least 8 years management experience, including personnel management
  • Working knowledge of relevant FDA, EU and ICH Guidelines
  • Experience working with CMOs, testing laboratories, service providers and relationship management preferred
  • Excellent auditing skills and ability to communicate significant observations etc. in a sound and factual manner
  • Ability to manage multiple projects in a fast-paced environment
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment
  • Ability to understand when issues require escalation to the Head of Quality
  • Ability to gain knowledge needed to assume responsibility for new programs and/or projects