Job Description
We are seeking a highly experienced Senior Quality Assurance Manager to lead our quality assurance functions at our state-of-the-art facility in Zurich. As a key member of the Operations leadership team, you will ensure that our products meet the highest standards of quality, safety, and efficacy in compliance with global regulatory standards.
In this role, you will drive a culture of continuous improvement, oversee complex GMP operations, and mentor a dedicated team of quality professionals. If you are passionate about regulatory compliance and want to make a tangible impact on the pharmaceutical industry, we want to hear from you.
Responsibilities
- Lead and manage the Quality Assurance department, ensuring full compliance with Swissmedic, FDA, and EMA regulations.
- Oversee the preparation and successful completion of internal and external GMP audits and regulatory inspections.
- Develop, implement, and maintain robust Quality Management Systems (QMS) across all manufacturing processes.
- Drive the CAPA (Corrective and Preventive Action) process to resolve deviations and systemic issues.
- Mentor and develop a high-performing team of QA professionals, fostering a culture of accountability and excellence.
- Collaborate with R&D and Production teams to integrate quality standards into the product lifecycle.
- Conduct risk assessments and implement quality risk management strategies.
Qualifications
- Master’s degree in Pharmacy, Chemistry, Biology, or a related Life Science field.
- Minimum of 5-7 years of experience in a Quality Assurance role within the pharmaceutical or biotechnology industry.
- Strong working knowledge of GMP (Good Manufacturing Practice) guidelines and regulatory requirements.
- Experience with Swissmedic and FDA regulations is highly preferred.
- Proven leadership experience with the ability to manage cross-functional teams effectively.
- Excellent analytical skills and attention to detail.
- Fluency in German and English is required.