Team Lead QA Ops 80-100% (m/f/d)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Located in Stein our successful CDMO Business Unit Drug Product Services (DPS) offers exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Team Lead QA Operations, Growth Project 80 – 100% supporting our new sterile Drug Product facility.

Key responsibilities:

• Execute establishment and maintenance of the Quality Oversight at DPS Manufacturing (aseptic manufacturing, process simulations (APS), environmental sampling, proper qualification of DPS staff in aseptic techniques)
• Lead and manage a team of at least 8 quality operations experts and develop them
• Review and approve protocols and reports for e.g. APS, holding time studies, cleaning studies, equipment/room qualification as applicable including documents in electronic systems (e.g. batch records, SOPs)
• Document Authoring, Review and approval including documents (e.g. batch records, SOPs)
• Supervise and execute GMP compliance activities like changes, non-conformities, document management, e.g. last approver of major deviations for manufacturing incl. executing the deviation review board and open requests to re-open TrackWise records via the TW support team
• Provide practical and theoretical trainings for e.g. Trackwise changes, personnel qualification
• Guide team members in line with Lonza values and behaviors including objective setting  performance evaluations, development planning and participate in the recruiting process
• Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps
• Establish and implement training and development plans
• Ensure effective use of resources (budget, time, personnel, systems)
• Counsel and support Sterile Production line functions, customers and groups in DPS like manufacturing, formulation and process development, business development in GMP compliance related issues in area of expertise
• Write/Contribute to internal compliance policy and/or comment to regulations
• Management and reporting of KPIs
• Represent QA Operations in inspections, audits and local and global initiatives
• Perform/support self-inspections and audits as required
• Enforce adherence to GMP for sterile manufacturing/aseptic filling (acts as fist contact concerning compliance issues / quality alerts for local and shared systems)
• Perform other duties as assigned
• Deputy of Head of QA Operations-Growth Project as required

Key requirements:

• University or academic degree (e.g. Masters) in Chemistry, Biology, Pharmacy or equivalent
• 10-15 years of professional experience in Quality Assurance and/or Quality Control in a manufacturing environment within the pharmaceutical Industry, preferably in Sterile manufacturing of drug products
• Proven record of 2-4 years of people management, of more than 6-8 direct reports
• Possess in-depth knowledge of Good Manufacturing Practice (GMP); sterile drug product aseptic manufacturing, Annex I regulations and ICH guidelines
• Experience in Swissmedic inspections, FDA inspections, and other health authorities is desired
• Exceptional leadership and people management skills. Interpersonal savvy – capable of managing multiple points of view and building partnerships
• Excellent communication, presentation and listening skills are a must for this role
• Ability to handle ambiguity and complexity of Growth Projects is a plus
• Relate to others in a team setting. Active listener seeking to understand and to be understood. Able to coach and manage experienced and inexperienced staff
• Fluency in English (spoken and written) is a must. At least B1 Level (spoken and written) in German is required

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.