Quality Manager (f/m/d) 100%
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.
- 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 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
This is the opportunity to be part of a fast-growing start-up company, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting to you, we are looking forward to hear more about you.
Please send all your documents (motivation letter, CV, letter of references, diplomas, etc.) to Ms. Sandra Gamboni, Global Head of HR, firstname.lastname@example.org
I am looking forward to your application!
Global Head of HR