The Quality Control (QC) laboratory at the site of STA Pharmaceutical Switzerland SA performs analytical and microbiological testing of incoming materials, packaging components, in-process samples, drug products, drug substances, and stability studies.
The QC Manager is responsible for the integration of New Product Introductions (NPI) within QC. This role requires strong leadership, problem-solving skills, and the ability to collaborate across departments to drive continuous improvement.
You will oversee the project management and on-time delivery of NPIs within QC, including method transfer or validation, analytical and microbiological testing, stability testing, and equipment cleaning residual testing for technical, registration, and clinical batches.
As the main point of contact between clients and QC activities, you will focus on customer needs while mentoring and coaching your team to foster a strong team spirit. Leveraging your experience, you will streamline QC processes, implement efficiencies, and drive operational excellence.
You will continuously improve processes to ensure compliance with cGMP, EHS, and industry best practices, including investigations, CAPAs, and change controls.
Responsibilities Manage, motivate, and coach a team of 8–10 direct reports to support NPI projects in QC.
Establish a training plan and ensure the continuous professional development of direct reports.
Oversee the day-to-day management of the team, including communication, organization, and feedback to ensure timely completion of activities.
Provide technical and scientific expertise to manage method transfer, verification, and validation; establish weekly planning for NPI projects.
Ensure the on-time delivery of NPI-related QC activities and project milestones.
Serve as the primary client contact, ensuring expectations are met by finding innovative solutions to complex problems through data collection, analysis, and application of risk management tools.
Ensure compliance with cGMP requirements and data integrity.
Write, review, and approve GMP documents.
Lead investigations of OOX results and deviations and establish effective CAPAs; initiate and manage Change controls.
Monitor KPIs, allocate resources effectively, and ensure performance targets are met.
Continuously improve lean lab initiatives such as 5S, deviation reduction, right-first-time execution.
Actively participate in inspections conducted by health authorities and clients.
Qualifications Master’s or PhD degree in Life Sciences, Chemistry, Pharmacy, or equivalent.
Minimum 10 years of QC experience in the pharmaceutical industry.
At least 4 years of team management and project management experience.
CDMO experience is highly advantageous.
Knowledge / Skills / Abilities In-depth understanding of cGMPs and their application in QC laboratories.
Strong scientific and practical knowledge of chromatography techniques (HPLC, UPLC, GC), dissolution, UV, Karl Fischer, etc.
Solid knowledge of analytical testing according to pharmacopeial requirements (including raw materials).
Strong documentation and technical writing skills.
Experience managing OOX, deviations, CAPAs and Change controls.
Experience organizing and scheduling QC testing activities.
Proven ability to lead and coach high-performing teams in an environment of trust and accountability.
Organized, rigorous, and open-minded in problem-solving.
Ability to act as Subject Matter Expert during regulatory inspections and audits.
Strong communication skills with team members, peers, management, and clients.
Committed to continuous improvement.
Fluent in French and English, both written and verbal.
#J-18808-Ljbffr