Quality Assurance Specialist

Lonza; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

An agile career and dynamic working文化

An inclusive and ethical workplace

Zusammenfassung

Lonza in Visp (Switzerland) is seeking an experienced QA professional to lead quality, compliance, and regulatory standards across biopharmaceutical projects. This fully site-based role emphasizes close collaboration for high-quality medicines.

You will review GMP documentation, manage deviations and CAPAs, and interact with Swissmedic and FDA. Mentoring junior staff and driving site-wide training are key components of the role.

Qualifikationen

• Academic degree in Chemistry, Biotechnology, Life Sciences, or a related scientific discipline.
• GMP-regulated biopharmaceutical or pharmaceutical experience, preferably in QA or Regulatory Affairs.
• Experience with biopharmaceutical manufacturing processes, tech transfers, and analytical methods.
• Familiarity with Swissmedic and FDA regulatory filings interactions.
• Experience managing deviations, change controls, CAPAs, and direct customer interactions.
• Excellent organizational, prioritization, and project management skills.
• Business-fluent English; German language skills are a strong advantage.

Aufgaben

• Serve as the quality and compliance authority for biopharmaceutical manufacturing processes across clinical and commercial customer projects.
• Review and approve critical cGMP documentation, including SOPs, Master Manufacturing Batch Records, and Material Specifications.
• Drive the resolution of deviations, out-of-specifications, and customer complaints using structured root cause analysis and CAPA management.
• Evaluate product-related changes and assess their impact on regulatory filings (FDA, Swissmedic), managing change control approvals with external customers.
• Represent QA within cross-functional project and tech transfer teams to ensure implementation of product safety and quality standards.
• Provide quality oversight for site and facility project initiatives to maintain compliance across IBEX operations.
• Train, mentor, and guide junior quality professionals and support site-wide cGMP training programs.

Kenntnisse

Business English

German (advantage)

Ausbildung

Chemistry/Life Sciences degree

Jobbeschreibung

Join our dynamic Quality Assurance team in Visp to lead quality, compliance, and regulatory standards across groundbreaking biopharmaceutical customer and facility projects. In this role, you will play a critical part in delivering life-changing medicines to patients worldwide through direct oversight and cross-functional leadership.

Fully site‑based roles

This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get:

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.

What you will do:

• Serve as the quality and compliance authority for biopharmaceutical manufacturing processes across clinical and commercial customer projects.
• Review and approve critical cGMP documentation, including Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, and Material Specifications.
• Drive the resolution of deviations, out-of-specifications, and customer complaints using structured root cause analysis and CAPA management.
• Evaluate product-related changes and assess their impact on regulatory filings (FDA, Swissmedic), managing change control approvals directly with external customers.
• Represent QA within cross-functional project and tech transfer teams to ensure seamless implementation of product safety and quality standards.
• Provide quality oversight for site and facility project initiatives to maintain optimal compliance across IBEX operations.
• Train, mentor, and guide junior quality professionals, fostering continuous development and supporting site‑wide cGMP training programs.

What we are looking for:

• Academic degree in Chemistry, Biotechnology, Life Sciences, or a related scientific discipline.
• Solid professional experience in the GMP-regulated biopharmaceutical or pharmaceutical industry, ideally in a Quality Assurance or Regulatory Affairs capacity.
• Practical knowledge of biopharmaceutical manufacturing processes, technical transfers, and analytical methods.
• Familiarity with interacting with health authorities such as Swissmedic and the FDA, alongside a strong grasp of regulatory filings.
• Demonstrated experience managing deviations, change controls, CAPAs, and direct customer interactions.
• Excellent organizational, prioritization, and project management skills with the ability to thrive in a fast-paced environment.
• Business-fluent English skills are required; proficiency in German is considered a strong 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.

Randstad is responsible for the engagement and contracting of this contingent role.