Senior QA Specialist, Customer Audit Management 80-100% (f/m/d)

Location: Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

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.

For our site in Visp we are looking for a Senior QA Specialist (Customer Audit Manager) (f/m/d) with a strong scientific background and experience in GMP manufacturing. He/She is responsible for the planning, execution and documentation of all customer audits and for the management of internal audits (self-inspections) and paper inspections by regulatory authorities. The Audit Manager also supports the QA Management in the preparation, execution and documentation of on-site regulatory inspections. The Audit Manager has face-to-face contact with Lonza’s customers on a regular basis and is therefore a key person for Lonza’s business.

What you’ll get: 

• An agile career and dynamic working culture

• An inclusive and ethical workplace

• Compensation programs that recognize high performance

• A variety of benefits dependant on role and location

The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits.

What you’ll do:

• Planning, executing and documenting customer audits on the Visp site

• Responding to customer requests for audit dates

• Planning audits together with Lonza project teams, based on the customers’ agendas

• Accompanying the customer throughout the audit (plant tours, documentation review etc.)

• Presenting Lonza’s Quality systems to the customer

• Documenting the customer audits in TrackWise

• Coordinating the responses to audit observations with the project team and ensuring that the customer receives the responses within the given timelines

• Providing KPI data to QA Management on a regular basis

• Conducting internal audits (self-inspections)

• Scheduling, preparing and performing internal audits as per approved audit schedule

• Agree on an appropriate CAPAs and monitor the implementation to a satisfactory conclusion

• Supporting QA management during regulatory inspections

• Organizing of preparation meetings and SME trainings

• Support in Front Office/Back Office as required

• Responsible for QA aspects of paper inspections

• Coordinating with Regulator Affairs to provide all required documents

• Answering queries from regulatory authorities with respect to paper inspections

What we’re looking for: 

• Academic degree in Chemistry/ Biotechnology/ Life Sciences etc

• Excellent communication skills in English and German (fluency in both languages is required)

• Professional appearance and attitude to establish and maintain excellent working relationship with customers

• Excellent verbal, written and interpersonal communications skills

• Excellent organizational skills

• Ability to work in partnership as an active member of a team and/or cross functional working groups

• Ability to prioritize and manage work to meet timelines in a fast-paced environment

• General knowledge of manufacturing processes and analytical methods

• Competent level of general IT skill (e.g. MS Office) is required

• Experience in auditing chemical/biopharmaceutical processes is an asset

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.