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Director, Quality Systems and Compliance

Reference Number: 3850
Location: MA

Our client is a well-financed start-up with a mission to improve personalized cancer treatments. We have been asked to identify candidates for their Director, Quality Systems and Compliance.

This is an excellent opportunity to develop the Quality Systems and Compliance function for the company, and support the development and implementation of quality systems to ensure that quality systems are in compliance with U.S and international regulations, laws, and guidelines. Reporting to VP of Quality, the Director of Quality Systems and Compliance will be accountable for quality systems including, but not limited to, training, documentation, quality metrics, audits and inspections, and will have the opportunity to create an influential and collaborative relationships for Quality across the company.

Major tasks and responsibilities will include: 

  • Create, implement, and oversee manage the company’s GxP Quality Management System including the Quality Policy and Quality Manual.
  • Oversee the electronic document control (EDMS) and training (LMS) systems.
  • Provide or support GxP/SOP training of all functional areas.
  • Coordinate and support the creation of and revisions to Standard Operating Procedures (SOPs).
  • Develop GxP audit schedules, oversee execution of audit plans, track audit reporting and corrective/preventative actions.
  • Oversee external vendors responsible for GxP audit activities.
  • Manage internal audits, mock recalls, and lead preparations for and support preapproval and routine regulatory agency inspections.
  • Collect and report of quality metrics via Quality Management Reviews and the Quality Council.
  • Provide guidance, interpretation and information pertaining to current GxPs to apply updates to the Quality System.
  • Provide long range planning of Quality System related activities including enterprise systems such as electronic document management, learning management, quality systems (Deviation, CAPA).
  • Promote and advance a Quality Culture.
  • Mentor staff and build processes that will drive innovation, teamwork and efficiency within the organization.
  • Work closely with management and other functions to design a Quality group that will effectively support the company's first NDA submission, product approval and commercialization.

 We seek candidates with the following qualifications:

  • A Bachelor’s Degree in Life Sciences, Chemistry, or related discipline; or a minimum of 10 years of experience in Biotech or Pharma with 5+ years of experience in Quality Systems management roles.
  • Proven ability to develop and implement GxP quality systems.
  • Knowledge of how to identify key quality metrics for maintaining compliance and identifying areas of improvement.
  • Experience facilitating inspections by regulatory agencies.
  • Understanding of domestic and international regulatory requirements.
  • Ability to effectively prioritize and manage multiple projects and tasks.
  • Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions.
  • At home in a results-driven, highly accountable environment where you can make a clear impact.
  • A team player, who listens effectively and invites response and discussion.
  • A collaborator who communicates in an open, clear, complete, timely and consistent manner.

If interested, please email your resume as a Word attachment to us, reference 3850.  No calls 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.