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Director Quality

Reference Number: 2979
Location: MA

Our client is a leading biotechnology company.  They have asked us to assist them in their search for a Director Quality.

The Contamination Control team reports directly to the site quality lead. The mission of this organization is to provide microbiologic expertise, investigative services and contamination control leadership ensuring that the site maintains robust aseptic control over the manufacturing environment.

Major tasks and responsibilities will include:

  • Actively involved in system design decision making and team meetings – insures systems are simple, sustainable, robust, and compliant.
  • Key participant in meeting consent decree work plan penalty milestones timelines for EM, bioburden, and critical utilities monitoring work plans.
  • Key participant in working to resolve issues to the Site Contamination Control Lead.
  • Helps to coordinate the execution of the environmental monitoring risk assessment and/or EQ studies to the CC site lead, Quality Assurance, the Environmental Action Committee (EAC) and senior leadership.
  • Coordinates work plans with Global Cell Banking (GCB) and other contamination control teams to ensure consistency of approach.
  • Works with the facilities and Equipment Project Upgrade Team to discuss the results of facility walkthroughs for installation and relocation of critical utility sampling sites.
  • Builds consensus across functional areas and obtain stakeholder agreement for Work Plan implementation.
  • Monitors revised processes and metrics to evaluate effectiveness of work plan implementation and continued sustainability.
  • Coordinates efforts with of CD teams and Contamination control team leads.
  • Works with the Viral Assessment Risk Management team to insure interoperability with Contamination Control CD Team.
  • Leadership to Environmental Action Committee (EAC).
  • Communication to senior management on all issues relating to contamination control.
  • Serves as Site Biosafety Officer and member of the Corporate Biosafety Committee.
  • Participates in all site leadership management reviews.
  • Investigation and impact assessment following microbiologic excursions.
  • Ensures that all relevant trending for environmental monitoring, bioburden and critical utilities monitoring is accurate, timely and actionable.
  • Ensures all relevant procedures including timely production of trending EAC minutes and quarterly trending reports in within stated timeframes and compliant IAW approved procedures.
  • Manages viral risk mitigation response and plan.
  • Provides Microbiology education programming and awareness to the site.
  • Provides technical guidance, professional development, and supervision to team members.
  • Ensures compliance with corporate Quality Operations standards pertaining to EM, bioburden, and critical utilities monitoring.
  • Provides leadership in conducting risk assessments pertaining to contamination control.

We seek candidates with the following qualifications:

  • Minimum of 10 years of experience in pharmaceutical manufacturing with a minimum of 8 years of experience in biopharmaceuticals/biotechnology applications.
  • Strong microbiology background or Life Science technical background.
  • 8 years in management or higher roles.
  • Good leadership, analytical, problem solving, and communication skills.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2979. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.