Quality Control Director - GMP Facility Paris (M/F)

Paris, France

Cellectis is seeking for a highly motivated individual to join its teams as a Quality Control Director. The successful candidate will work as part of the Pharmaceutical Compliance  team of Cellectis  Paris and will be responsible for the set up and management of a new GMP  testing facility in Paris, and for the recruitment and management of the associated new QC team.

Published on May 31, 2019

He/She will be responsible for the supervision of QC strategy and testing on Cellectis GMP/High Quality Grade Raw and Starting Material (Plasmids, mRNA, Viral Vectors), ensuring compliance with regulatory requirements in EU, and US, accuracy, consistency across Cellectis family products and cost effectiveness.

He/She advises on and coordinates the QC activities related to the development and clinical investigation of Products, associated devices and laboratory equipment.

The Quality Control Director is also a crucial link between Cellectis GMP facility, subcontracted testing facilities and various stakeholders.

Skills requirements

  • Strong and current knowledge of cGMP compliance and strong cGMP Compliance in the activities of the CMC function, related to cell and gene medicinal products.
  • Interfaces with regulators, inspectors and can interpret cGMP to solve technical issues using scientific compliant solutions.
  • Familiarization with Quality Systems (OOS, CAPA, Deviations, etc.)
  • In addition, works independently on complex technical problems in which analysis of situations or data requires in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
  • Strong leadership and interpersonal skills
  • Skilled in achieving results and managing others to achieve corporate, and departmental objectives.
  • Excellent communication skills, good presentation and influencing skills
  • Ability to interact with and gain the support of senior management and peers
  • Ability to work cooperatively in teams and peer relationships
  • Ability to effectively manage multiple, complex priorities

Qualifications and training requirements

  • A relevant postgraduate qualification (PhD or research-based MSc, or PharmD). Post-doctoral research, practical research or laboratory work experience is required.
  • 10 years of experience in pharmaceuticals or a related industry with 5 years in QC positions. Or, an equivalent combination of education and experience.
  • Expertise and experience in development and implementation of molecular and cellular-based QC (PCR, cell-based assay)
  • Knowledge of pharmaceutical and/or biotechnology principles
  • In depth knowledge of quality and chemistry philosophies, systems, methods, tools and standards
  • Broad cGMP experience and knowledge of regulatory compliance (EU US and other international agencies)