QA Supplier Manager – Raw Materials

Raleigh, USA

The QA Supplier Manager is responsible to set up and organize QA activities related to Cellectis GMP and High-Quality-Grade Raw Materials activities.The successful candidate will be responsible for the QA auditing and oversight of suppliers/distributors of GMP and High-Quality-Grade Raw Materials, anticipate and prepare Cellectis to obtain Raw Materials for Clinical Phase 3 and BLA/MA Cellectis products, including oversight of multiple suppliers in multiple location (EU/US), to ensure consistency of supplies, compliance to regulations, and compliance with regulatory filings.

Published on November 22, 2019

RESPONSIBILITIES:

  • Maintaining expert knowledge in quality and regulatory requirements and GMP guidelines and ensuring that the requirements are implemented accordingly internally at Cellectis and at our suppliers.
  • Participating in developing, maintaining, and improving the Pharmaceutical Quality System within the GMP area.
  • Develop and implement the Supplier Management System.
  • Draft or review and approve GMP and High-Quality-Grade Raw Materials Quality SOPs.
  • Providing QA expertise to the organization and quality for GMP and High-Quality-Grade Raw Materials activities.
  • Manage the quality events linked to the GMP and High-Quality-Grade Raw Materials, such as Out of Specification, deviation, non-conformity, change, and lead investigation, CAPA implementation.
  • Lead risk assessment of GMP and High-Quality-Grade Raw Materials and suppliers.
  • Review and approve GMP and High-Quality-Grade Raw Materials’ Specifications.
  • Formally approve the GMP and High-Quality-Grade Raw Materials for Cellectis’ use and maintain the Approved Supplier List.
  • Review and evaluate suppliers for the quality aspects, set up and review of quality agreement/procedures with our suppliers.
  • Prepare audit plans and audit/risk mitigation plans as needed.
  • Perform routine and non-routine quality assurance audits to include: supplier sites, processes, systems and document to assure quality assurance compliance with regard to all internal procedures as well as quality and regulatory guidelines.
  • Perform supplier audits.
  • Clearly communicate and report (verbally and in writing) audit outcomes to the rest of organization, and escalating quality issues as required.
  • Manage and/or deliver yearly GMP Raw Materials training for internal staff.
  • Proactively assist the organization in preparation, coordination, hosting, conducting, documentation and follow up for regulatory inspections.
  • Participate in drafting and review of relevant sections for IND/CTA.

POSITION REQUIREMENTS:

  • Bachelor’s Degree in Life Science (Pharmacist, Human Biologist, Biochemistry etc.)
  • 8 years of relevant QA experience within the pharmaceutical industry, which includes practical experience in regulatory inspection preparation and conduct.
  • Knowledge of pharmaceutical and/or biotechnology principles.
  • Experienced Auditors within the GMP area preferred.
  • Experience in gene editing is a plus.
  • Experience in Cell and Gene Therapy is a plus.
  • Strong understanding of Quality processes with flair for the practical angle to creatively reach a compliant solution.
  • Exceptional verbal and written communication skills.
  • Proficiency in Word, Excel, and PowerPoint.
  • Risk analysis method knowledge.
  • Ability to identify and communicate QA associated Risks.
  • Ability to prioritize, maintain a positive attitude and thrive in a fast paced and changing environment.
  • Ability to travel (mainly in the EU and USA).
  • Result and goal-oriented and committed to contributing to the overall success of Cellectis QA.