Global Quality Ops Lead CMO Oversight (Biologics)

Join; Neuenburg; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

Join is seeking a Quality Operations Manager to oversee CMOs in a global external manufacturing environment, ensuring full compliance with cGMP and international standards for biologics drug substance and drug product manufacturing. The role is based in the French-speaking part of Switzerland within a dynamic cross-functional virtual plant team.

Starting ASAP, this 6-month temporary contract requires a bachelor’s degree in a scientific discipline, 4+ years in pharmaceutical operations, and at

Qualifikationen

• Bachelor’s degree in a scientific discipline is required.
• Minimum 4 years’ experience in pharmaceutical operations at the manufacturing site.
• At least 2 years in quality, ideally in product release.
• Experience in biologics / sterile manufacturing and CMO oversight.
• Strong knowledge of cGMP, deviation management, CAPA and risk assessment.
• Experience with SAP/QMS systems and strong technical writing skills.

Aufgaben

• Provide quality oversight of Contract Manufacturing Organizations (CMOs).
• Manage and review product disposition (batch documentation, deviations, change controls, complaints).
• Ensure compliance with cGMP, regulatory filings and Quality Agreements.
• Support inspections, audits and inspection readiness activities.
• Escalate quality risks and ensure timely resolution of compliance issues.

Kenntnisse

GMP knowledge

QA oversight

SAP/QMS

Technical writing

Risk assessment

Deviation management

CAPA

Biologics manufacturing

Ausbildung

Bachelor’s degree in a scientific discipline

Tools

SAP

QMS

Jobbeschreibung

Join is seeking a Quality Operations Manager to oversee CMOs in a global external manufacturing environment, ensuring full compliance with cGMP and international standards for biologics drug substance and drug product manufacturing. The role is based in the French-speaking part of Switzerland within a dynamic cross-functional virtual plant team.

Starting ASAP, this 6-month temporary contract requires a bachelor’s degree in a scientific discipline, 4+ years in pharmaceutical operations, and at