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Senior Director, GMP Quality Assurance

Reference Number: 4012
Location: MA

Our client is a clinical-stage biopharmaceutical company. They have asked us to assist them in their search for a Senior Director, GMP Quality Assurance.

Major tasks and responsibilities will include:

  • Responsible for the Quality group that oversees GMP activities.
  • Develops and implements risk-based Quality strategies for investigational and commercial materials.
  • Ensures that quality-related tasks and requirements are completed to support the release of raw materials, drug substance, drug product, and finished goods.
  • Oversees GMP vendor management.
  • Leads the development, execution, and upkeep of Quality Systems and SOPs related to GMP activities.
  • Trains staff on global GMP regulations and guidances.
  • Confirms that CDMOs are operating in compliance with the quality program, regulations/guidelines and SOPs.
  • Leads and/or oversees CDMO audits. Develops, Recommends, and follows-up on corrective actions.
  • Leads Quality investigations.
  • Oversees the outcome of appropriate CAPAs associated with investigations, deviations, product complaints and recalls.
  • Provides quality input and oversight for process validation, process performance qualification, and continuous process verification.
  • Quality oversight of commercial distribution, logistics, and launch activities.
  • Leads CDMO inspection-readiness preparations.
  • Serves as SME for areas of responsibility during regulatory inspections.
  • Collaborates with Technical Operations and Regulatory to identify and mitigate quality risks.
  • Assists with the establishment of metrics.
  • Reports the state of CDMO GMP Quality and compliance.
  • Ensures Clinical Development activities are compliant with cGCP, cGLP, FDA, ICH, EMA regulations and guidelines, as well as industry standards.
  • Provides consultation in the interpretation of regulations and guidelines as they apply to GCP practice, awareness of regional regulatory requirement, and phase of study.
  • Stays abreast of industry developments, such as forthcoming regulations, guidance, best practices, etc.

We seek candidates with the following qualifications:

  • Bachelor’s degree in a related field required. Advanced degree highly preferred.
  • Must have a minimum of 15+ years of pharmaceutical manufacturing, packaging, and laboratory experience.
  • Must have a minimum of 10+ years of experience in GMP QA/QC/Compliance.
  • Requires the demonstrated ability to lead direct reports and cross-functional teams.
  • Direct experience managing Health Authority Inspections required.
  • Must have excellent communication, writing and presentation skills for effectively interfacing with internal and external organizations, collaborators and customers.
  • The ability to assess complex issues, break down into components and propose viable solutions is required.
  • Requires excellent knowledge of Global GMP regulations and industry standards.
  • Proficiency in study monitoring activities required.
  • Must be knowledgeable of the infrastructure and operational characteristics of CDMOs.
  • Must be willing to travel domestically and internationally up to 25-35%.

If interested, please email your resume as a Word attachment to us, reference 4012.  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.