Essential Job Functions:

Continuous Improvement

•   Manage and participate in cross‑functional projects aimed at enhancing operational performance, reducing waste, and improving product quality.
• Drive standardization by harmonizing project processes in QC and ensuring compliance with operational standards.
• Optimize the training process within the QC laboratory.
• Develop and implement data‑driven continuous improvement strategies using methodologies such as Lean, Kaizen, and Six Sigma.
• Continuously improve lean laboratory initiatives, including 5S, deviation reduction, and permanent inspection readiness.
• Analyze data (KPIs) to identify trends, bottlenecks, and areas for improvement, and implement strategies to address these issues.
• Foster a culture of continuous improvement by engaging teams in problem‑solving activities and promoting best practices.
• Initiate, own, and follow up on QC‑related change controls, managing all involved stakeholders.
• Lead specific OOX laboratory investigations and deviation investigations, including deviation initiation, impact assessment, and establishment of corrective and preventive actions (CAPAs) based on root cause analysis.
• Work closely with the QC team and cross‑functional departments to ensure investigations are thorough and complete; initiate and manage related change requests through to closure.
• Follow up on and implement assigned CAPAs.
• Author and/or review documentation, including TWIs and SOPs, to support process improvements.
• Actively participate in client audits and health authority inspections.
• Prepare and present reports on quality performance, audit outcomes, and improvement initiatives to management and stakeholders.
• Collaborate with cross‑functional teams to ensure alignment on quality and continuous improvement objectives.

EHS:

• Report immediately all incidents and near-misses to EHS, participate in investigations and identify preventive measures to avoid similar accidents in the future.

Job Requirements:

Experience / Education

• Master or PhD degree in Life Sciences, Chemistry, Pharmacy or equivalent with Lean Management certification (Green Belt)
• At least 5 years in continuous improvement activities in Quality Control in a pharmaceutical company
• OSD and / or CMO experience highly advantageous

Knowledge / Skills / Abilities:

• Thorough understanding of relevant cGMPs and regulatory requirements, along with their practical application to ensure laboratory compliance.
• Strong scientific and practical knowledge of analytical techniques, including chromatography (HPLC, UPLC, GC), dissolution, UV/Vis, Karl Fischer, etc.
• Solid knowledge of analytical testing in accordance with Pharmacopeia requirements, including raw material testing.
• Strong analytical, structured, problem‑solving, influential, and deductive skills.
• Well organized, rigorous, and detail oriented.
• Ability to act as a Subject Matter Expert (SME) during regulatory inspections and audits (e.g. QC processes and procedures, deviations).
• Demonstrates a strong drive for continuous improvement.
• Excellent oral and written communication skills in French and English.