Head QA, Manufacturing Equipment Qualification Cqv 80-100%

**Location: Stein (Switzerland)**

Today, Lonza is a global leader in life sciences operating across five 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.

Are you looking for a unique opportunity to integrate a Greenfield project (building several new production lines) into the existing manufacturing environment? As Head Quality CQV you will be part of the Site Quality Leadership team, shaping the quality landscape at Lonza AG in Stein

What you’ll get:

- An agile career and dynamic working culture
- An inclusive and ethical workplace
- Compensation programs that recognize high performance
- Along with competitive salaries, you’ll find a wide range of lifestyle, family and leisure benefits available. The full list of our local benefits can be also found on assetstream.aspx

Key responsibilities:

- Establish and maintain the Equipment Qualification System at Lonza Drug Product Services (DPS), including the commissioning, process and computerized systems validation, qualification of manufacturing equipment.
- Lead and develop a team of QA Experts, guiding them in line with Lonza’s values and behaviors, including objective setting, performance evaluations, development planning, and participation in the recruiting process. Support a culture of high performance and trust, ensuring the required level of knowledge and skills are available and identifying proficiency gaps
- Ensure accurate qualification of equipment, infrastructure, and computerized systems by adhering to corresponding VMP(s). Support and ensure the implementation of global procedures related to CQV. Serve as the first contact for overarching documents related to equipment, infrastructure, and computerized systems qualification & maintenance within QA.
- Supervise compliance activities such as GMP status and trending of equipment, qualification/re-qualification in relation to supplier qualification, changes, nonconformities, CAPAs, audit/inspection/self-inspection observations, and document management
- Collaborate with other sites and global teams to improve and align CQV processes within Lonza. Ensure decisions are fully supported by global and local Quality and Regulatory standards
- Ensure effective use of resources (budget, time, personnel, systems)
- Coordinate the qualification of equipment suppliers/services by supervising adherence to quality agreements and audit observations. Track GMP status of service providers, including calibration, maintenance, and consultants

Key requirements:

- Degree or equivalent experience in Life Science, Engineering, or a related field
- Several years of leadership experience is a prerequisite
- Work experience in Quality Assurance
- Solid experience in qualification topics within the pharmaceutical, GMP-controlled sterile manufacturing area, including solid CQV experience is crucial
- Experience with audits, including being part of the front office is a must; experience specifically with Swissmedic is an advantage
- Demonstrated assertiveness to uphold quality standards and make decisive calls in fast-paced environments with opposing priorities
- Proficiency in English is a must; language skills in German are a plus

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

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.