Job Description

This position supports the entire QC team in continuous improvement activities at the STA Pharmaceutical Switzerland SA site. The Specialist QC Operational Excellence plays a pivotal role in ensuring that products and processes meet stringent quality standards while fostering a culture of ongoing enhancement and improvement.

The Specialist QC Operational Excellence supports the QC team with improvement projects, including the optimization of material, personnel, and waste flows through lean principles, process improvements, and the updating of procedures.

You will support GMP compliance by working closely with the QC Compliance Specialist within the QC laboratory, contributing to in‑depth root cause investigations of compliance issues and to the identification and implementation of CAPAs.

You will also work closely with QC peers (on site and across other STA sites) as well as internal departments (Supply, Production, Quality, etc.) on compliance and continuous improvement activities.

Responsibilities

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.

Qualifications

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.