Quality Manager
vor 1 Woche
**Quality Manager (f/m/d) 100%. Visp, CH**:
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**:
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 and German
**My Reason 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.
Sandra Gamboni
Global Head of HR
-
Quality Manager
vor 7 Monaten
Visp, Schweiz Bacthera VollzeitBacthera 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...
-
Quality Assurance Manager
Vor 5 Tagen
Visp, Schweiz Lonza VollzeitToday Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
-
Visp, Schweiz Vaxcyte Vollzeit**Join our Mission to Protect Humankind!** Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease,...
-
Sr. Manager, Quality Control
Vor 4 Tagen
Visp, Schweiz Vaxcyte VollzeitJoin our Mission to Protect Humankind!Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group...
-
Production Quality Manager
vor 7 Monaten
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...
-
Quality Assurance Expert
vor 7 Monaten
Visp, Schweiz Arxada VollzeitArxada is a pioneering leader with a powerful legacy: Over 120 years of creating specialty chemicals and solutions that potentiate the performance of our customers and their products. Our solutions, our expertise and our support help them to perform better - to be more efficient, more effective and more sustainable. We are passionate about empowering high...
-
Production Quality Manager
Vor 5 Tagen
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...
-
Associate Director, Quality Assurance
vor 7 Monaten
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...
-
Manager, Quality Assurance, Polysaccharide
vor 2 Wochen
Visp, Schweiz Vaxcyte Vollzeit**Join our Mission to Protect Humankind!** Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease,...
-
Associate Director, Quality Control
vor 3 Monaten
Visp, Schweiz Vaxcyte Vollzeit**Join our Mission to Protect Humankind!** Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease,...
-
Sr. Manager, Quality Assurance Cqv
vor 3 Monaten
Visp, Schweiz Vaxcyte Vollzeit**Join our Mission to Protect Humankind!** Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease,...
-
Manager, Manufacturing Quality Assurance, Raw
vor 1 Monat
Visp, Schweiz Vaxcyte Vollzeit**Join our Mission to Protect Humankind!** Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease,...
-
Head Quality Systems
vor 7 Monaten
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...
-
Visp, Schweiz Vaxcyte VollzeitJoin our Mission to Protect Humankind!Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group...
-
QA Manager, Project Quality Lead
vor 6 Monaten
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...
-
QA Manager
Vor 7 Tagen
Visp, Schweiz Bacthera VollzeitBacthera 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...
-
QA Project Manager
vor 3 Monaten
Visp, Schweiz Lonza Vollzeit**Title**: Quality Assurance - Project Manager **Location**: Visp Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we...
-
Quality Assurance Manager Csv
Vor 5 Tagen
Visp, Schweiz Lonza VollzeitSwitzerland, Visp Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas,...
-
QA Project Manager
vor 6 Monaten
Visp, Schweiz Coopers Group AG Vollzeit**QA Project Manager** Responsible for providing daily oversight, tactical and strategic leadership for a team of QA Project Managers directly supporting the internal and external customers Key management deliverables are to provide general leadership, guidance and support to ensure QA Project Managers are providing internal and external customers, with...
-
Project Manager Quality Assurance Pcp
vor 6 Monaten
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...