Job Summary (Primary Function)
The QC Raw Materials & Stability Supervisor is responsible for the QC operational activities related to Drug Substance (DS) and Drug Product (DP) raw and incoming materials sampling and testing and for stability study management at Incyte QC Bioplant. This includes (but is not limited to) testing planning and scheduling, the definition/coordination of required analyses, management of sampling activities (planning and coordination) and the review and approval of internal and external results/data within defined lead times. The role acts as a primary point of contact for activities under his/her ownership and involving Quality Assurance, Manufacturing, Supply Chain, Warehouse, other QC teams, and external laboratories. The supervisor owns deviations, CAPA and change controls related to the QC activities under his/her responsibilities.
Essential Functions Of The Job (Key Responsibilities)
* Leadership & Management
o Supervise, mentor, and develop QC personal within the team.
o Plan and allocate daily laboratory activities to meet testing schedules and manufacturing timelines.
o Ensure appropriate training, qualification and workload coverage (including planning for absences).
* Laboratory Operations (Raw Materials & Stability)
o Accountable for routine and non-routine sampling and testing of raw and incoming materials (DS/DP-related).
o Ensure effective stability study management, including sample management, planning, scheduling, tracking, and coordination of testing and reporting.
o Support the implementation of new analytical methods and new equipment relevant to the scope of testing.
o Ensure adherence to Good Manufacturing Practices (GMP) and all relevant regulatory standards (FDA, EMA, ICH, Pharmacopoeias).
o Ensure QC equipment used within the scope is appropriately qualified and maintained as fit-for-purpose for cGMP activities.
o Troubleshoot analytical instruments and technical issues to maintain laboratory efficiency and data integrity.
* Quality & Compliance
o Review and approve laboratory data, test results, and associated documentation in accordance with procedures and delegated authority.
o Lead investigations related to OOS/OOT, deviations, and non-conformances, ensuring timely and robust conclusions.
o Maintain up-to-date SOPs, protocols, and training records to ensure regulatory compliance.
o Participate in audits and inspections and support responses/corrective actions within the scope.
* Continuous Improvement & Projects
o Drive process improvements, including automation and digitalization initiatives, to enhance efficiency and compliance.
o Participate in method verification, transfer, and lifecycle management activities.
o Collaborate with cross-functional teams (Manufacturing, QA, Regulatory Affairs, Development) to support product lifecycle activities and inspection readiness.
o Provide input to QC budget planning and operate within the approved budget for the scope.
Qualifications (minimum Education, Experience, And Competencies)
* Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, or related field with 10+ years of relevant laboratory experience; or an advanced degree (MSc/PhD) with 7–10+ years of relevant experience.
* Strong experience in a GMP environment within biotechnology or pharmaceutical industry.
* Previous QC laboratory supervision experience required, including ability to set direction, set expectations, and motivate performance.
* Proven experience with Quality Systems (Deviation, CAPA, Change Control).
* Strong knowledge of analytical testing and compendial requirements (e.g., Pharmacopoeias).
* Ability to work in a highly regulated and fast-changing environment.
* Strong team spirit, proactive and pragmatic approach; rigorous, organized, and able to propose solutions and summarize complex topics.
* Languages: French (fluent) and English (advanced; C1).
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