QA Supplier Manager – Raw Materials

Paris, France

Cellectis is looking for an experienced and dedicated QA Supplier Manager to be part of our Quality Corporate team.

“QA Supplier Manager” is responsible to set up and organize QA activities related to Cellectis GMP and High-Quality-Grade Raw Materials activities. “QA Supplier Manager” is responsible for the QA oversight of the GMP and High-Quality-Grade Raw Materials related tasks linked to outsourced GMP and High-Quality-Grade Raw Materials Cellectis’ subcontractors. “QA Supplier Manager” is responsible to anticipate and prepare Cellectis goal to obtain GMP Raw Materials for Phase 3 and BLA/MA Cellectis’ products, including supervising multiple subcontractors, in multiple location (EU/US), ensuring consistencies, compliance to regulation and compliance with regulatory filings.

Published on December 04, 2019

“QA Supplier Manager” is also a crucial link between various stakeholders including:

  • Manufacturing team
  • Quality Control team
  • Supply Chain team
  • Quality Assurance Team
  • Regulatory Team
  • Translational Team
  • Subcontractors
  • Auditors

The key responsibilities include but are not limited to:

  • Maintaining expert knowledge in quality and regulatory requirements and GMP guidelines and ensuring that the information is implemented accordingly internally at Cellectis and at our sub-contractors.
  • Participating in developing, maintaining and improving the Pharmaceutical Quality System within the GMP area.
  • Develop and implement GMP and High-Quality-Grade Raw Materials QA 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.
  • Ensure QA oversight of GMP and High-Quality-Grade Raw Materials document as requested.
  • 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 linked subcontractors.
  • Review and approve GMP and High-Quality-Grade Raw Materials’ Specifications.
  • Formally approve the GMP and High-Quality-Grade Raw Materials for Cellectis’ use.
  • Reviewing and evaluating of contract partners (i.e., subcontractors) for the quality aspects, set up and review of quality agreement/procedures with our subcontractors.
  • Preparing audit plans and audit/risk mitigation plans as needed.
  • Performing routine and non-routine quality assurance audits to include: subcontractors sites, processes, systems and document to assure quality assurance compliance with regard to all internal procedures as well as quality and regulatory guidelines.
  • Perform subcontractors audits together or not with certified/qualified auditor.
  • Clearly communicating and reporting (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.
  • Providing advice internally and externally on GMP Raw Materials and quality matters within the Manufacturing, Quality Control and Supply Chain operations.
  • Proactively assisting the organization in preparation, coordination, hosting, conducting, documentation and follow up for regulatory inspections.
  • Participate in regulatory filling drafting and review for IND/CTA.

Key skills:

  • Collaborative and strategic minded.
  • Customer focused and able to deal with ambiguity.
  • 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 see QA, Manufacturing, Quality Control and Supply Chain teammates as a valuable resource and desire to further build on the team to maintain effective working relationships throughout the GMP area at Cellectis.
  • 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, Manufacturing Operations

Please be sure to quote the reference Cellectis, QA-Supplier in the subject line of your email application.