Quality Operations Manager – External Manufacturing
Share
Job Location:
Neuchâtel - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
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 12 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:
- Bachelors 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
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
