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Project Lead QC
Remote / Online - Candidates ideally in
Stein, Appenzell Ausserrhoden, Switzerland
Listed on 2026-07-15
Stein, Appenzell Ausserrhoden, Switzerland
Listing for:
Lonza Group Ltd.
Remote/Work from Home
position Listed on 2026-07-15
Job specializations:
-
Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Location: Stein
The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. The role is primarily site‑based; however, remote work is allowed for no more than 20% of the time, subject to case‑by‑case business needs.
Benefits- An agile career and a dynamic work culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- Competitive salary plus numerous lifestyle, family, and leisure benefits.
- Full list of global benefits available at
- Lead and coordinate QC related project activities for release and stability testing of late‑phase (PPQ) and commercial drug products, with a focus on large molecules and Antibody Drug Conjugates (ADCs).
- Serve as primary QC representative and project champion, driving project execution through effective coordination of timelines, deliverables, customer engagements, and stakeholder communication in close partnership with Program Managers.
- Assess laboratory capacity and manage analytical method transfers, ensuring timely implementation of testing to meet customer and project requirements.
- Implement analytical testing strategies, including method suitability assessments, performance evaluation, control strategies, and specification setting.
- Author quality records and cGMP documents (e.g., procedures, source documents, reports, deviations, change requests).
- Act as QC subject matter expert during audits, inspections, and customer meetings while ensuring GMP‑compliant documentation and regulatory readiness.
- Work experience in a GMP‑regulated pharmaceutical QC environment with a sound understanding of analytical testing of biologics (large molecules) is required.
- Strong collaboration and stakeholder management skills, with confidence to coordinate activities, provide constructive challenge, and interact effectively with customers and internal teams.
- Experience in project coordination, analytical method validation and/or method transfer is a strong advantage.
- Fluency in English is required; fluency in German is a plus.
- Degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related life sciences discipline.
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