Manager, Quality Systems and Documentation

  • Location:Cambridge,MA
  • Department:Quality
  • Type:Full Time
  • Min. Experience:Mid Level

RESPONSIBILITIES:

  • Participate in the development of quality strategies for support of global clinical trials
  • Provide Quality support to establish and maintain policies and procedures for quality function as well as provide guidance/review/approval of policies and procedures within these functional areas
  • Assist in the development, tracking and management of the annual audit plan.
  • Provide support for the development, implementation and management of GxP electronic document management systems and data/document retention system.  In lieu of the electronic systems, management of a manual system.
  • Manage the quality system including deviation, investigation, CAPA, change control, supplier change notices, and training.
  • Assist in hosting regulatory inspections, as necessary, and help with the development of responses to regulatory agency questions and/or findings.  Track regulatory commitments to completion.
  • Contribute to the continuing development of a quality culture
  • Build and foster cross-functional partnerships throughout the organization
  • Support projects as assigned by Manager.

 

EDUCATION AND EXPERIENCE: 

  • BS/BA, in a science related discipline and a minimum of 8 years’ experience biotech and/or pharma.
  • Working knowledge of relevant FDA, EU and ICH Guidelines related to cGxPs.  GxP audit experience would be a plus.
  • Experience developing and working in GxP Quality Systems with some experience and/or working knowledge of GCP and GLP activities.
  • 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 tasks.