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

Lonza; Oberwallis; Presencial; Vertraulich; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Agile career culture

Inclusive workplace

Performance-based compensation

Role/location benefits

Resumo da oferta

Lonza in Visp, Switzerland, seeks a Senior QA Specialist / Customer Audit Manager with GMP experience to lead customer audits, internal audits (self-inspections) and regulatory inspections, and to support QA management.

You will coordinate audits with project teams, present Lonza’s quality systems, document findings in TrackWise, and ensure timely CAPA actions while maintaining strong customer relationships. Fluent English and German and a science background are required.

Qualificações

• Academic background in Chemistry, Biotechnology or Life Sciences.
• Strong communication in English and German.
• Excellent organizational and interpersonal skills.
• Ability to work with cross-functional teams and manage timelines.
• Experience with GMP manufacturing and audits is required or asset.

Responsabilidades

• Plan, conduct and document customer audits at the Visp site.
• Respond to audit date requests from customers.
• Plan audits with project teams per customer agendas.
• Accompany customers during audits (tours, document reviews).
• Present Lonza's Quality systems to customers.
• Document audits in TrackWise.
• Coordinate audit observation responses and ensure timely delivery.
• Provide KPI data to QA management regularly.
• Conduct internal audits (self-inspections).
• Schedule and perform internal audits per schedule.
• Agree on CAPAs and monitor implementation.
• Support QA management during regulatory inspections.
• Organize prep meetings and SME trainings.
• Support Front/Back Office as required.
• Oversee QA aspects of paper inspections.
• Coordinate with Regulatory Affairs for documents.
• Respond to regulator queries on paper inspections.

Conhecimentos

GMP experience

Audit management

Quality systems

Regulatory inspections coordination

Cross-functional collaboration

Formação académica

Chemistry/Biotechnology/Life Sciences degree

Ferramentas

TrackWise

MS Office

Descrição da oferta de emprego

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

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 will 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 will 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 are 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

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.