Quality Operations Manager – External Manufacturing

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

External Manufacturing – GMP Oversight & CMO Management

Are you an experienced Quality Operations professional (m/f/d) looking to take ownership in a global external manufacturing environment?

Our client is seeking a motivated Quality Operations Manager to provide quality oversight of Contract Manufacturing Organizations (CMOs) and ensure full compliance with cGMP and international regulatory standards for biologics drug substance and drug product manufacturing.

The position is based in the french speaking part of Switzerland, within a dynamic cross-functional virtual plant team. Startin ASAP this is a temporary contract lasting 6 Months.

Your Responsibilities:

• 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

Your Profile:

• Bachelor’s degree in a scientific discipline (e.g. Pharmacy, Biochemistry, Microbiology)
• 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
• Fluent English required, German/Italian/French as a second preffered language
• German basics