Manager, Global Quality Engineering

vor 22 Stunden

Bern, Schweiz CSL Behring Vollzeit

CSL Behring is a global biotherapeutics leader driven by its promise to save lives.

For our Bern Site, we are currently looking for a

**Manager, Global Quality Engineering (100%)**:
The Manager Global Quality Engineering is responsible for quality oversight of GMP compliant realization of CAPEX and OPEX commercial portfolio projects at the CSL Behring Bern.

This role will provide quality oversight and review of design activities and GxP documentation for of CAPEX & OPEX commercial portfolio projects at the CSL Behring Bern site relevant to Global Engineering.

**Key Responsibilities**
- Support Global Engineering (Process Engineering & Project Delivery) in the following fields during project phases: Vendor Qualification, Commissioning & Qualification, Process Life Cycle, Methods Transfer and Stability
- Quality oversight of the GMP-compliant realization of CAPEX and OPEX projects
- The role will focus on Commissioning & Qualification and Process Life Cycle activities
- The incumbent is responsible for Commissioning & Qualification, focusing on:

- Determining the requirements for the quality of supply and manufacturing systems and rooms while taking the Process Design into account
- Review and approve risk analyses, user requirements (URS), qualification plans, interim reports, and qualification protocols in CAPEX and OPEX projects
- Execution of GxP supplier qualification activities
- Process Life Cycle:

- Quality oversight for technology transfers (risk assessments, protocols and reports) and Quality by Design (QbD)
- Quality Oversight for PPQ validation and support studies, cleaning validation, life cycle management
- The incumbent works closely with members of Global Engineering and supports the other Global Quality Engineering fields
- QA Manager for local and global change requests related to engineering activities
- Analyse deviations and SQuIPP assessments related to engineering activities and determine corrective or preventive actions to correct the deficiencies and avoid their occurrence in the future

**Your skills and experience**
- Degree in life sciences and/or engineering; Advanced degree preferred
- 5+ years of experience as professional in the pharmaceutical industry or equivalent combination of education and experience.
- Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, TGA, EU, and other regulatory agency guidelines and in manufacturing of biologics
- Direct experience in quality oversight of GMP-compliant commissioning and qualification of production facilities, equipment, and cleanrooms and within a manufacturing and/or engineering context
- Strong quality process knowledge (SOP review & Approval, Deviation (oversight), Changes)
- Experience in interacting with regulatory authorities including submissions and inspections
- Ability to influence at all levels of the organization through clear, concise and effective communication
- Good organizational and interpersonal skills
- Collaborate effectively with internal and external colleagues and stakeholders
- Experience in project-oriented working methods
- Effective use of German and fluent English skills (spoken and written)
- CSL Behring is committed to providing equal employment opportunities for all._

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Behring**:

  • Manager, Quality Engineering Methods Transfer

    vor 7 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    **The Opportunity** Reporting into the Quality Engineering Methods Transfer & Stability Leader, the Methods Transfer & Stability Manager will provide QA oversight for projects covering methods transfer & stability. The individual will partner with the process and product owners of Capex projects at the Bern manufacturing site and will support QA oversight...

  • Quality Control Manager

    vor 7 Monaten

    Bern, Schweiz Tiger Recruitment Ltd Vollzeit

    **Quality Control Manager** We have an excellent opportunity for an experienced Quality Control Manager to join a renowned Swiss cosmetics business. You will have knowledge within the industry including experience working to ISO27716 standards, together with advanced English and French languages. **Responsibilities** - Responsible for the quality and...

  • Engineering Manager

    vor 7 Monaten

    Bern, Schweiz Johnson & Johnson Vollzeit

    Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion...

  • Global Quality Assurance Manager for CMO Partnerships

    vor 2 Monaten

    Bern, Bern, Schweiz CSL Behring Vollzeit

    We are seeking a highly skilled Global Quality Assurance Manager to join our team at CSL Behring. This role will be responsible for managing and supporting production efforts at Contract Manufacturing Organizations (CMOs) and providing quality oversight for outsourced operational activities.The successful candidate will have a thorough understanding of...

  • Global Regulatory Cmc Manager

    Vor 5 Tagen

    Bern, Schweiz We make it GmbH Vollzeit

    We make it GmbH is a company operating nationally in Switzerland, which has a high level of competence in the personnel services sector thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest...

  • Global Regulatory Cmc Manager

    Vor 6 Tagen

    Bern, Schweiz We make it Vollzeit

    Beschreibung: We make it GmbH is a company operating nationally in Switzerland, which has a high level of competence in the personnel services sector thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH...

  • Manager, Quality Assurance Operations

    Vor 7 Tagen

    Bern, Schweiz Emergent Biosolutions Vollzeit

    Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life. As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats. We value the diversity that each employee brings, and while we look for people who share our...

  • Process Lead Quality Management

    vor 7 Monaten

    Bern, Schweiz CSL Behring Vollzeit

    **Responsibilities**: **Quality Management Processes** - Represent and own the global Quality / EBR processes for all Manufacturing Sites and Affiliates. - Manage a team of Manager Level Professionals to ensure continuous process improvements and adherence to Global Standards. - Ensure full compliance with Quality Requirements of Regulatory Agencies and...

  • Global Quality Oversight Manager for CMOs in EMEA Region

    vor 2 Wochen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    We are seeking a highly skilled and experienced Global Quality Oversight Manager to join our team at CSL Behring. This is an exciting opportunity for a professional with a strong background in quality assurance and regulatory compliance to play a key role in ensuring the high-quality delivery of medicinal products.The successful candidate will be responsible...

  • Regional Quality Oversight Manager EMEA for Global Pharmaceutical Company

    Vor 6 Tagen

    Bern, Bern, Schweiz CSL Behring Vollzeit

    CSL Behring is seeking a highly skilled Regional Quality Oversight Manager to join our team in EMEA. This role will be responsible for managing and supporting production efforts at Contract Manufacturing Organizations (CMOs) and providing quality oversight for outsourced operational activities.The successful candidate will have a strong understanding of...

  • Global Labeling Associate/ Global Regulatory

    vor 7 Monaten

    Bern, Schweiz We make it Vollzeit

    Beschreibung: We make it GmbH is a company operating nationally in Switzerland, which has a high level of competence in the personnel services sector thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH...

  • CH - Project Manager 2, Engineering

    vor 17 Stunden

    Bern, Schweiz Johnson & Johnson CH Vollzeit

    Job Post has been updated successfullyJob Share Recipient EmailJob DescriptionShare: Email, Facebook, Twitter, LinkedIn, PrintCH - Project Manager 2, Engineering[Rehhagstrasse 79, 3018], Bern - Switzerland | Posted - 05/06/23OverviewDescription:Janssen Vaccines in Bern (Switzerland) is part of the Janssen Pharmaceutical Companies of Johnson & Johnson....

  • Manager, External Supply QA Cmo Quality Operations

    Vor 5 Tagen

    Bern, Schweiz CSL Behring Vollzeit

    Reporting to the Associate Director, External Supply Quality Assurance, you will be responsible for managing and supporting global drug substance and drug product production efforts at Contract Manufacturing Organizations (CMOs). The Manager will work with CMO’s and cross-functional internal teams to transfer new processes, manage changes, resolve issues,...

  • Quality Assurance Associate

    Vor 6 Tagen

    Bern, Schweiz We make it Vollzeit

    Beschreibung: We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We at it GmbH set the highest...

  • Quality Assurance Associate

    Vor 6 Tagen

    Bern, Schweiz We make it GmbH Vollzeit

    We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We at it GmbH set the highest standards for...

  • Vp of Engineering

    vor 2 Wochen

    Bern, Schweiz SettleMint Vollzeit

    **Accelerating the Web3 transformation journey** We are remote-first and put skills and cultural fit on the same level supporting both vertical and lateral career progression opportunities for top performing team members. **The role** As the VP of Engineering you will lead and grow our exceptional team of engineers, and own all aspects of the engineering...

  • Quality Assurance Manager

    vor 7 Monaten

    Bern, Schweiz Panda International Vollzeit

    **Quality Assurance Manager**: **Location** - Bern, Switzerland **Business Sector** - Pharmaceutical **Job ref** - 22249 **Published** - about 7 hours ago Our client, a renowned pharmaceutical company based in Switzerland, is seeking a highly skilled and experienced Quality Assurance Manager to lead and oversee the quality management functions within the...

  • Quality Assurance Manager

    vor 7 Monaten

    Bern, Schweiz BMK Recruitment Vollzeit

    We are currently looking on behalf of one of our clients based near Bern for a Quality Assurance Manager. This is a permanent role. Aufgaben - manage tests on products at different stages of production to ensure the quality level - define the measurement procedures - be the central point of contact for product test-related matters - be the central point of...

  • Global Regulatory Affairs Manager Cmc Gene Therapy

    vor 2 Wochen

    Bern, Schweiz We make it Vollzeit

    Beschreibung: We make it GmbH is a company operating nationally in Switzerland, which has a high level of competence in the personnel services sector thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH...

  • Quality Assurance Project Manager for Pharma

    vor 22 Stunden

    Bern, Schweiz agap2 - HIQ Consulting Vollzeit

    Founded in 2005, agap2 is a European company of engineering and operational consulting. We operate in the sectors of Energy, Infrastructure, Transport, Chemistry, Life Sciences and IT. Today, the agap2 group has a team composed of over 5000 qualified doctors and engineers. We work on projects around the world from our offices in Europe - Switzerland,...