QA PM III-Operations (Biotech)

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.

At Lonza AG, we offer an outstanding opportunity for a highly motivated and experienced Quality Assurance Project Manager III (QA PM III) to join our team! The QA PM III will serve as the primary liaison to our sophisticated external customers for quality-related items, ensuring an outstanding execution of our projects!

Responsibilities

• Work well with internal and external customers as part of the Joint and Internal Project Teams, serving as the Quality Subject Matter Expert.

• Review and approve various product-specific documents, including Process Validation Reports, Quality Agreements, Annual Product Reviews, Master Batch Records, Deviation Reports, and Change Controls.

• Facilitate discussions between customers and internal groups such as MSAT, Manufacturing, Engineering, and QC to efficiently implement quality-related projects and initiatives.

• Complete the process for advising customers and addressing their feedback and comments, ensuring quality records are detailed with sound justifications and scientific rationale.

• Lead Joint Quality Team (JQT) meetings for assigned external customers by establishing agendas, publishing meeting minutes, and supervising action items.

• Attend Internal and Joint Project Team (IPT/JPT) meetings as the QA representative, keeping track of and sharing monthly and quarterly critical metrics.

• Mentor less experienced staff on the team and provide direct support to management.

• Develop effective strategies to address customer inquiries and improve operational processes to maintain high standards.

Requirements

• Education: A Bachelor's degree in a related field or equivalent experience is required.

• Experience: A minimum of 10 years of validated experience in QA project management within the life sciences industry.

• Expertise in handling change controls, deviations, standalone investigations, CAPAs, Product Quality Reviews, and Quality Agreements.

• Validated capability to effectively collaborate with both internal and external collaborators to identify and implement standard methodologies.

• Strong leadership and mentorship skills with a track record of guiding teams to challenge at the highest levels.

• Outstanding attention to detail and the ability to work independently with minimal direction.

• Excellent communication and interpersonal skills to ensure all customer service expectations are closely met.

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.

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.