Quality Recruiting. Established Experts.

Director of Quality Assurance

Reference Number: 3732
Location: MA

Our client is a biopharmaceutical company. They have asked us to assist them in their search for a Director of Quality Assurance.

Major tasks and responsibilities will include:

  • Continues to build the Quality System to ensure regulatory and industry standards are met.
  • Provides guidance, interpretation, and information pertaining to current GMPs, GCPs, and GLPs to apply updates to the Quality System including SOPs, Policies and Specifications.
  • Initiates and manages the review and approval of SOPs.
  • Supports the CMC team with batch record review, change control, and investigations.
  • Supports GxP training of functional areas and contributes to the development of appropriate training for internal and external personnel.
  • Devises GxP audit schedule, oversees execution of audit plans and audits, reviews audit reports, and tracks corrective/preventive actions associated with key sites and contract service providers.
  • Ensures that all required aspects of the Quality Management System are trended on a routine basis for presentation to senior management.
  • Manages the internal audit programs.
  • Manages a team of 1 to 3, and manages contractors/consultants

We seek candidates with the following qualifications:

  • Requires an undergraduate degree.
  • Must have a minimum of 10 years of pharmaceutical or biotech industry experience.
  • Must have a minimum of 5 years of experience in Quality Systems management roles.
  • Must have a minimum of 5 years of GMP experience.
  • Requires in depth knowledge of GMP regulations, principles, concepts, industry standards.
  • GLP and GCP experience highly preferred.
  • Must know how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement.
  • Requires understanding of domestic and international regulatory requirements.
  • Requires strong analytical skills and the demonstrated ability to translate strategy into action.

If interested, please email your resume as a Word attachment to us, reference 3732.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.