Senior QA Specialist - QA Projects 80-100% (f/m/d)

Lonza; Oberwallis; On-site; Vertraulich; Full time

Benefits offered by this job

Agile career path

Inclusive workplace

Compensation programs that recognize高

Job summary

Lonza in Visp, Switzerland, is seeking a Senior QA Specialist to own quality responsibilities for biopharmaceutical manufacturing processes used in clinical and commercial supply. You will serve as QA in project teams, ensuring cGMP compliance and timely change controls.

You will review records, drive deviations investigations, and support regulatory filings while mentoring junior staff and advancing QA strategies. Fluency in English with German a plus.

Qualifications

• Academic degree in Chemistry/ Biotechnology/ Life Science or any related field.
• Solid experience in the GMP regulated pharmaceutical industry is required; preferably in a QA role.
• General knowledge of biopharmaceutical manufacturing processes and analytical methods.
• Experienced in the interaction with health authorities (Swissmedic, FDA etc.).
• Ability to oversee project execution to identify non-compliance from quality standards. Ability to prioritize and manage work to critical project timelines in a fast-paced environment.
• Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.
• Strong team orientation with excellent verbal, written and interpersonal communication skills.
• Business fluent English is required, good German skills - an advantage

Responsibilities

• Own all quality related responsibilities for the manufacturing processes of biopharmaceutical products for clinical and commercial supply. Represent QA in project/tech transfer organizations for new biotech manufacturing processes.
• Responsible for review and final release of records like SOPs, Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
• Perform assessments for all product-related changes, assesses relevance to regulatory filings, decide to implement and provide change controls for approval to customers where required.
• Ensure all deviations are appropriately investigated and recorded, direct the investigations of customer product complaints and assure the completion of the appropriate documentation.
• Identify emerging QA relevant topics, communicate to the IBEX QA organization and work actively on their development into new or already established Quality and Compliance strategies and/or standards.
• Train and mentor junior Lonza employees to better accomplish and perform in their duties as Quality professionals. Support cGMP training programs to ensure staff is being trained.

Skills

QA leadership

Regulatory liaison

Biopharma know-how

Team collaboration

Education

Chemistry/Biotech/Life Science degree

Job description

Location:

The actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

The role:

The Senior QA Specialist (f/m/d) for QA Projects specifies quality requirements for manufacturing processes and cGMP standards over their entire life cycle. As a Quality and Compliance representative he/she will be a key member in cross-functional project teams ensuring measures for product safety, product quality & cGMP compliance are implemented.

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:

• Own all quality related responsibilities for the manufacturing processes of biopharmaceutical products for clinical and commercial supply. Represent QA in project/tech transfer organizations for new biotech manufacturing processes.

• Responsible for review and final release of records like Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.

• Perform assessments for all product-related changes, assesses relevance to regulatory filings, decide to implement and provide change controls for approval to customers where required.

• Ensure all deviations are appropriately investigated and recorded, direct the investigations of customer product complaints and assure the completion of the appropriate documentation.

• Identifie emerging QA relevant topics, communicate to the IBEX QA organization and work actively on their development into new or already established Quality and Compliance strategies and/or standards.

• Train and mentor junior Lonza employees to better accomplish and perform in their duties as Quality professionals. Support cGMP training programs to ensure staff is being trained.

What we are looking for:

• Academic degree in Chemistry/ Biotechnology/ Life Science or any related field.

• Solid experience in the GMP regulated pharmaceutical industry is required; preferably in a QA role.

• General knowledge of biopharmaceutical manufacturing processes and analytical methods.

• Experienced in the interaction with health authorities (Swissmedic, FDA etc.).

• Ability to oversee project execution to identify non-compliance from quality standards. Ability to prioritize and manage work to critical project timelines in a fast-paced environment.

• Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.

• Strong team orientation with excellent verbal, written and interpersonal communication skills.

• Business fluent English is required, good German skills - an advantage

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.