Biopharma QA & Compliance Lead (On‑Site)

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

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.