Quality Assurance Manager
vor 7 Monaten
**Quality Manager (f/m/d) 100%**
A leading contract development and manufacturing partner (CDMO) for biotech and pharma customers is seeking a Quality Manager. The role involves commissioning, qualification, and process validation of a new manufacturing facility, as well as establishing the quality management system and processes to ensure compliance with national/international requirements and cGMP standards.
**Main responsibilities**:
- Involved in quality-related activities for manufacturing processes
- Review and approval of documents such as Standard Operating Procedures, Master Manufacturing Batch Records, Deviation Reports, Change Requests, Qualification/Validation Protocols and Reports, etc.
- Ensure appropriate investigation and recording of manufacturing deviations
- Manage investigations of customer product complaints and ensure timely completion of documentation
- Drive completion of Corrective and Preventive Actions (CAPA) and effectiveness check items
- Perform Batch record reviews for Drug Substance and Drug Product on behalf of the Responsible Person
- Evaluate product-related changes, assess relevance to regulatory filings, provide change notifications, and approve change requests
- Manage life cycle management of all manufactured products in compliance with GMP
- Represent QA in project/tech transfer teams for new manufacturing processes
- Support and participate in internal and external audits, including inspections by health authorities
- Identify emerging QA topics, communicate to the organization, and contribute to the development of Quality and Compliance strategies and standards
- Support GMP training programs
- Promote a strong Quality culture within the organization
**Your profile**:
- Bachelor's or Master's degree in biotechnology, pharmacy, life science, or related field
- Over 3 years of experience in the GMP regulated pharmaceutical industry, preferably in a quality and compliance role in production and CAPEX projects
- Strong knowledge of GMP regulations
- Strong team orientation
- Structured, focused, and well-organized working attitude
- Open-mindedness for new ideas and suggestions
- Agile, highly motivated, and dynamic drive
- Solution-oriented mindset
- Experience in representing Quality and Compliance in the operational manufacturing environment
- General knowledge of manufacturing processes and analytical methods
- Ability to identify non-compliance with quality standards during project execution
- Ability to prioritize and manage work in a fast-paced environment with critical project timelines
- Good operational level of English, German language skills are an asset
**Organization and offer**:
The organization is a prominent contract development and manufacturing partner (CDMO) in the biotech and pharma industry. With headquarters in Basel, Switzerland, and production facilities in Denmark and Switzerland, they are dedicated to enabling their biotech and pharma customers to deliver life-changing treatments to patients. Setting themselves apart as the first CDMO globally to offer a complete supply chain for manufacturing live bacteria strains for therapeutic use, they bring together exceptional capabilities and expertise.
**Quality Manager (f/m/d) 100%**
A leading contract development and manufacturing partner (CDMO) for biotech and pharma customers is seeking a Quality Manager. The role involves commissioning, qualification, and process validation of a new manufacturing facility, as well as establishing the quality management system and processes to ensure compliance with national/international requirements and cGMP standards.
**Main responsibilities**:
- Involved in quality-related activities for manufacturing processes
- Review and approval of documents such as Standard Operating Procedures, Master Manufacturing Batch Records, Deviation Reports, Change Requests, Qualification/Validation Protocols and Reports, etc.
- Ensure appropriate investigation and recording of manufacturing deviations
- Manage investigations of customer product complaints and ensure timely completion of documentation
- Drive completion of Corrective and Preventive Actions (CAPA) and effectiveness check items
- Perform Batch record reviews for Drug Substance and Drug Product on behalf of the Responsible Person
- Evaluate product-related changes, assess relevance to regulatory filings, provide change notifications, and approve change requests
- Manage life cycle management of all manufactured products in compliance with GMP
- Represent QA in project/tech transfer teams for new manufacturing processes
- Support and participate in internal and external audits, including inspections by health authorities
- Identify emerging QA topics, communicate to the organization, and contribute to the development of Quality and Compliance strategies and standards
- Support GMP training programs
- Promote a strong Quality culture within the organization
**Your profile**:
- Bachelor's or Master's degree in
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