The company seeks an Associate Director of QA for a major growth project in Stein, Switzerland. This role involves leading a QA team, defining quality strategy, and ensuring compliance with global regulatory standards within a fast-paced manufacturing environment.
This position sits within a high-energy project environment dedicated to establishing new commercial production lines and advancing manufacturing capabilities. The role is primarily site-based in Stein, Switzerland, with the option to work remotely up to 20% of the time.
Responsibilities
- Guide, mentor, and expand the QA Expert team.
- Define and drive the overarching Quality strategy.
- Collaborate with Senior Project Directors and leadership to align manufacturing and support functions with strategic goals.
- Serve as the primary subject matter expert for major quality and GMP challenges.
- Establish, oversee, and sustain the local Quality System.
- Support the creation and upkeep of global quality systems, ensuring alignment with corporate standards and regulations from Swissmedic, US FDA, and European authorities.
- Independently review and approve project documentation.
- Participate in investigations, troubleshooting efforts, audits, and regulatory inspections.
- Spot opportunities to refine operational procedures to boost quality and efficiency.
- Foster a learning environment and facilitate knowledge sharing across teams.
Requirements
- Proven experience in direct-line leadership roles.
- Strong agility, assertiveness, and communication abilities suited for a dynamic project phase.
- Eligibility to act as a deputy for the Qualified Person/FvP in Switzerland or the EU.
- Extensive background in senior QA positions within GMP-controlled pharmaceutical manufacturing.
- Deep understanding of ICH, PIC/S, EU, and US regulatory requirements and their practical application.
- Experience handling customer audits and inspections from agencies like Swissmedic, USFDA, EMA, and MHRA.
- University degree in Life Sciences, such as Pharmacy or Biology.
- Fluent proficiency in English.
- Basic knowledge of German.
Nice to have
- Experience with aseptic fill and finish processes.
What the company offers
- Relocation support for eligible candidates and their families.
- An agile career path within a dynamic work culture.
- An inclusive and ethical workplace environment.
- Compensation structures that reward high performance.
- A competitive salary package.
- Various lifestyle, family, and leisure benefits.
About the company
Lonza operates across more than 30 sites on five continents, with globally connected teams collaborating daily to manufacture the medicines of tomorrow. The company values diversity and fosters an inclusive environment where unique perspectives drive innovation. Core values of Collaboration, Accountability, Excellence, Passion, and Integrity guide how employees work together, with the belief that every idea has the potential to improve millions of lives.
- People are considered the greatest strength.
- Global collaboration across 30+ sites on five continents.
- Core values include Collaboration, Accountability, Excellence, Passion, and Integrity.
- Commitment to diversity and an inclusive environment.
- Innovation driven by diverse perspectives.
- Belief that every idea can improve millions of lives.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.