Bacthera is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.

Create your own future as

Quality Manager (f/m/d) 100%

The QA Manager, as a member of the QA Unit, be involved in the commissioning, qualification and process validation of a new manufacturing facility and in the establishment of the quality management system and process, thus ensuring Quality oversight and compliance with national/international requirements and cGMP standards.

 

My main tasks will be…

• involved in all quality related activities for the manufacturing processes
• Responsible for review and approval of documents such as Standard Operating Procedures, Master Manufacturing Batch Records, Deviations Reports, Change Requests, Qualification/Validation Protocols and Reports etc
• Ensure all manufacturing related deviations are appropriately investigated and recorded
• Direct the investigations of customer product complaints and assures the timely completion of the appropriate documentation
• Responsible to drive CAPA and effectiveness check items to completion and timely closing
• Perform Batch record reviews for Drug Substance and Drug Product on behalf of the Responsible Person
• Evaluate product-related changes, assesses relevance to regulatory filings, provides change notifications for endorsement to customers where required and approves the change requests
• Ensure an efficient GMP compliant life cycle management of all products manufactured
• Represent QA in project/tech transfer teams for new manufacturing processes.
• Support and approves project/product specific risk assessments
• involved and support internal and external audits (incl. inspections by health authorities)
• Identify emerging QA relevant topics, communicates to the organization and work actively on their development into new or already established Quality and Compliance strategies and/or standards
• Support GMP training programs to ensure staff is being trained
• Actively support the Quality culture as a role model

 

I bring with me…

• Bachelor degree, Master degree in biotechnology, pharmacy, life science or related field
• More than 3 years of experience in the GMP regulated pharmaceutical industry, preferably in a quality and compliance role in production and CAPEX projects
• Strong background GMP regulations
• Strong team orientation
• Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
• Solution-oriented
• Experienced in representing Quality and Compliance in the operational manufacturing environment
• General knowledge of manufacturing processes and analytical methods
• Ability to oversee project execution to identify non-compliance from quality standards
• Ability to prioritize and manage work to critical project timelines in a fast-paced environment
• A good operational level of both English; German is an asset

 

My reasons for choosing Bacthera…

• Innovative and fast growing start-up company with short decision-making processes
• Flexible working hours (possibility of Home Office)
• Motivated, agile and multinational team
• Very good pension fund and attractive salary
• Fringe benefits (e.g. Lunch card, deduction at different stores, Job ticket for public transport)
• Interesting and diversified tasks

Bacthera AG
Frau Sandra Gamboni
Global Head of Human Resources
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