Sr. Quality Specialist

Our Gene Therapy client here in Cambridge, MA is growing and looking to bring on board a Sr. QA Specialist to oversee external Quality!  This role will manage the quality activities at CMOs, CTOs and to serve as the Quality Lead for external partnerships. Role will be responsible for managing all activities associated with product disposition and release testing at CMOs and CTOs. The ideal candidate will have experience in the Biopharmaceutical industry in QA and QC.  Responsibilities will include but not limited to:

  • Author, review and approve GMP documentation (SOPs, batch records, protocols, technical reports, test methods, protocols, specifications, and summary reports to support GMP manufacturing).
  • Quality Assurance Lead for external collaborations to provide quality system expertise and help identify solutions and ensure compliance to GMP.
  • Support External Quality partnerships as required in the initiation and follow up of deviations, CAPAs, and change controls..
  • Build on relationships within CTOs and CMOs ensuring issues impacting quality control testing are tracked and resolved in a timely manner.
  • Responsible for compliance with documentation management system (quality agreements, CMO performance evaluations, master batch records, analytical data, etc.).
  • Support projects, and global processes alignment (internal and external) as well as continuous improvement and initiatives.
  • Review executed batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, and that all limits and specifications have been met.
  • Review and approve deviations, change controls and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations.
  • Develop and maintain Quality Agreements with contract manufacturers, suppliers, and laboratories
  • Independently coordinates complex investigations in cross-functional areas.
  • Anticipate issues and escalate to appropriate management attention immediately.
  • Exercises judgment in resolving moderate to complex quality issues.
  • Supports the organization in maintaining inspection readiness.
  • Review and approve validation protocols and reports to ensure compliance
  • Review analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans
  • Support generation of metrics for Management Review
  • Review stability protocols and reports
  • Conduct internal and external audits as required, track progress, and trend results
  • Occasional travel will be required

 

Requirements:

  • Bachelor’s or Master’s degree in biology, chemistry or other life science and at least 5 years of relevant industry experience in Quality Assurance in a Pharmaceutical/Biotech GMP environment
  • A solid understanding of applicable regulations and guidelines pertaining to pharmaceutical product development. manufacturing, testing and clinical operations
  • Experience with GMP’s in a working manufacturing environment
  • A working knowledge of GMP requirements for Clinical Trial Material in both the US and EU including sterile manufacturing strongly preferred
  • Certified Quality Auditor (CQA) would be a plus
  • Investigational skills including Root Cause Analysis and Product Impact Assessments