Description du poste et des missions
The Quality Control (QC) department is divided in two teams at DNA Script : one team in France, in charge of performing QC of reagents produced in France (enzymes, nucleotides, resins and buffers) and one team in South San Francisco (SSF), in charge of performing the QC of our instruments (Syntax) and the reagents produced in SSF.
We are looking for a QC Manager (FR) to create and develop the Quality Control team and activities in Paris. It is an excellent opportunity to create a lab, define a strategy and have a huge impact on fast-growing company.
The QC Manager (FR) reports to the Quality and Regulatory Director.
Create and structure the QC department in Paris office
Manage the QC team (2 engineers), hire new people and supervise the daily activities of the laboratory (UPLC, capillary electrophoresis, UV spectrophotometry, DNA synthesis, NGS, PCR, SDS-Page)
Develop QC processes in the lab in compliance with ISO requirements to implement best practices and ensure top-quality for our reagents
Support establishment and maintenance of QC labs (lab organization, instrument / equipment calibration, preventative maintenance, purchase, lab cleaning, etc).
Approve the results obtained, establish CoA to release reagents
Manage trend analysis
Perform root cause investigation and lead Quality Operational events related to the department (Out of Specifications results, Nonconformance, CAPA, Change Control, )
Review documentation (SOP, Batch Manufacturing Records, Work Instruction, Test Protocol, )
Be the point of contact for team concerning Reagents QC-related topics, represent QC in meetings as a QC Subject Matter Expert
Work closely with the QC team leader based in the US (instruments and standard reagents QC) and various departments to ensure new documentation or processes comply with Quality requirements
Inspire and foster a strong Quality culture, mentor staff and organization for development and growth
Perform other duties as assigned
Qualifications and experience
Bachelor’s / Master’s Degree or PhD in a related field with minimum of 8 years’ experience in Quality Control in a biotechnology / pharmaceutical setting.
Familiarity with ISO 9001, ISO 13485, 21CFR820, or biotech manufacturing and a thorough knowledge and understanding of GMP
Experience in the biotech / pharma industry
Demonstrated leadership, high organizational and prioritization skills
Attention to detail and problem solving
Excellent written and verbal communication skills
Job located in Le Kremlin Bicêtre (Paris area)
Start date : As soon as possible.
Recruitment Process :
Initial screening with the hiring manager
Day interview at the office (or remote) with the manager, cofounders, HR and the rest of the team
Timing : 2-3 weeks