Quality Assurance Manager (GMP) – English Speaking

Über das Unternehmen

Lonza is a global partner to the pharmaceutical, biotech and nutrition industries. We help our customers to bring new and innovative products to market that improve the lives of people around the world. Headquartered in Basel, Switzerland, Lonza operates across five continents, with a global network of sites and more than 16,000 employees. We are dedicated to providing the highest quality products and services, driven by a commitment to scientific excellence and operational efficiency.

Stellenbeschreibung

We are seeking an experienced and highly motivated Quality Assurance Manager with a strong background in Good Manufacturing Practices (GMP) to join our team in Dietikon. The successful candidate will be responsible for overseeing and managing all aspects of the Quality Management System (QMS) to ensure compliance with global regulatory requirements (e.g., Swissmedic, FDA, EMA) and internal standards. This role requires an individual who can lead a team, drive continuous improvement initiatives, and maintain a robust quality culture within our manufacturing operations. Fluency in English is essential for this role, enabling effective communication across our international network and with regulatory bodies.

Hauptverantwortlichkeiten

• Manage and oversee the Quality Management System (QMS) to ensure ongoing compliance with GMP regulations and corporate standards.
• Lead and mentor a team of QA professionals, fostering a culture of quality and continuous improvement.
• Plan, conduct, and manage internal and external audits (supplier audits, regulatory inspections) and ensure timely resolution of findings.
• Oversee deviation investigations, CAPA (Corrective and Preventive Action) effectiveness checks, and change control processes.
• Review and approve batch records, validation documents, and other GMP-critical documentation.
• Participate in product lifecycle management, including new product introduction and technology transfers, providing QA oversight.
• Act as a primary contact for regulatory agencies during inspections and provide expert guidance on quality-related matters.
• Drive continuous improvement initiatives within the QA department and across manufacturing operations.

Erforderliche Fähigkeiten

• Minimum 6 years of experience in Quality Assurance within a GMP-regulated pharmaceutical or biotechnology environment.
• Demonstrated expertise in GMP principles and international regulatory requirements (Swissmedic, FDA, EMA).
• Proven leadership and team management experience.
• Strong understanding of Quality Management Systems (QMS) and their implementation.
• Excellent analytical, problem-solving, and decision-making skills.
• Fluency in English (written and spoken) is mandatory.
• Ability to effectively communicate and collaborate with cross-functional teams and external stakeholders.

Bevorzugte Qualifikationen

• Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Certified Quality Auditor (CQA) or equivalent certification.
• Experience with sterile manufacturing processes or biologics.
• Proficiency in German is a plus, but not required.

Vorteile & Zusatzleistungen

• Competitive salary and attractive bonus scheme.
• Comprehensive health and social insurance benefits.
• Generous vacation and holiday policy.
• Opportunities for professional development and continuous learning.
• Dynamic and international work environment.
• Employee assistance programs and wellness initiatives.
• Access to state-of-the-art facilities and technology.

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