Process Lead Quality Management

vor 6 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 Quality Institutions.
- Lead business process management for major projects and initiatives (e.g., Country Specific Planning and Release).
- Manage the process for establishing and maintaining effective process measurement by Identifying and managing a set of key performance indicators for the Quality processes.
- Ensure implementation of globally consistent and best practice processes for Quality Assurance and Quality Control.
- Focus on often complex process areas, which requires extensive investigation and analysis.
- Interact with Quality functional leads to align project and improvement priorities.
- Act as change agent for the respective business area.

**Lead global Process/I&T projects from a business point of view**:

- Deliver Overall Project Management aspects according to CSL standards and best practices on a global scale.
- Create business requirements.
- Co-create business processes with technical partners.
- Lead User Acceptance Testing activities.
- Ensures training materials are developed and trainings executed.
- Ensures cut over and go live activities are thoroughly planned and executed successfully.

**Organizational Impact**
- Initiate and push change on within the global CSL network from and partner with global site leadership as well as business associates in the manufacturing and supply chain and network strategy areas around the globe.
- Driving positive, digital and data driven cultural development within the organization through awareness, organization change management and sharing the importance of reliability and digital supply chain capabilities.
- Act as change agent for the respective area.

**Leadership and Talent Development**
- Manage a team of experienced Sr. Business Process Analysts and SMEs with a global footprint at each CSL manufacturing site.
- Manage and escalate resource related topics to avoid any impact to projects timelines, budget and value realization.

**Qualifications**:

- Bachelor’s or master’s degree in quality management, engineering, or related field and/or MBA a plus.
- 5-10 years of experience in Quality Management, Supply Chain Management Operations or related field
- 7+ years' experience with ERP as reporting systems (SAP QM, MS PowerPlatform).
- Excellent knowledge of quality processes including integration with planning
- and execution systems
- Demonstrated success in project management and continuous improvement processes in a global matrix organization.
- Agile mindset.
- Knowledge of pharmaceutical / biological manufacturing, GxP and regulatory standards, and environments.
- SAP proficiency is strongly preferred.
- Experience with setting up paginated reports and dashboards within PowerBI.
- English language fluency, German language is a plus.

**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**:



  • Bern, Bern, Schweiz CSL Behring AG Vollzeit

    We are seeking a highly skilled Quality Assurance Leader to join our team at CSL Behring AG.Job DescriptionAs a Quality Assurance Leader, you will be responsible for ensuring the quality of our pharmaceutical products and processes. This includes overseeing site Bern as an agent of globally owned processes quality management system, managing deviations,...


  • Bern, Bern, Schweiz CSL Behring Vollzeit

    About the Role:CSL Behring is seeking a highly skilled Lead GMP Process Specialist to join our team. In this role, you will be responsible for overseeing the quality processes and standards across the network in your area of responsibility.Key Responsibilities:Develop and implement Globally Owned Processes Quality Management SystemMaintain Site Bern...


  • Bern, Bern, Schweiz CSL Behring AG Vollzeit

    Job DescriptionThis role involves leadership in implementing and maintaining quality processes within pharmaceutical operations at CSL Behring AG.Key Responsibilities:Ensure adherence to Globally Owned Processes (GOP) and cGMP standards as the Site Bern agent of the Quality Management System.Maintain site ownership through effective Deviation Management,...


  • Bern, Schweiz Helvetica Partners Vollzeit

    We are currently looking on behalf of one of our important clients for a Risk Management Team Leader (German Speaking). The role is a permanent position based in Bern Canton & comes with good home office allowance. Your Role: - Oversee the technical & personnel management of a Risk Management team consisting of 8 employees. - Ensure & continuously...


  • Bern, Schweiz Panda International Vollzeit

    **Director of Quality Management (QMS)**: **Location** - Bern, Switzerland **Business Sector** - Biotechnology **Job ref** - 22245 **Published** - 3 days ago Our client, a biotech company at the forefront of innovation, is seeking a Director of Quality Management to continue their growth trajectory in Switzerland. **Key Responsibilities**: - Develop...


  • 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...


  • Bern, Bern, Schweiz CSL Vollzeit

    About CSLCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases.Clinical Portfolio Management RoleWe are seeking an experienced Lead Clinical Portfolio Management Specialist to join our team. In this role, you will be responsible for establishing and managing standards and processes...


  • Bern, Schweiz CSL Behring Vollzeit

    This role requires significant international travel. **Responsibilities**: - Lead transition of technical oversight from project (tech transfer) to operations phases for DP external manufacturing - Ensure that key parameters for process monitoring are identified and charts (e.g. time series, control charts) are set up and maintained - Ensure key process...


  • Bern, Schweiz CSL Behring Vollzeit

    This role requires significant international travel. **Responsibilities**: - Lead transition of technical oversight from project (tech transfer) to operations phases for DP external manufacturing - Ensure that key parameters for process monitoring are identified and charts (e.g. time series, control charts) are set up and maintained - Ensure key process...


  • Bern, Schweiz CSL Behring Vollzeit

    For our location in Bern, we are currently looking for a **Process Analytical Technology (PAT) Lead Bern**: In this interesting role you will work at the interface of analytical method development, process optimization and full-scale operations. You will have responsibility for improvement projects and represent PAT in cross-functional teams with local and...

  • Lead Auditor

    vor 1 Monat


    Bern, Schweiz headcount AG Vollzeit

    Lead Auditor (Biotech) Our client based in Bern is seeking support for their Audit Team, an experienced Lead Auditor (6 - 12 month contract).  Key Responsibilities:Conduct onsite audits and manage supplier qualificationSupport Supplier Quality Management (SQM) processes, including SQM database.Assist with maintenance and clean-up of supplier...

  • Lead Auditor

    vor 4 Wochen


    Bern, Schweiz headcount AG Vollzeit

    Lead Auditor (Biotech)Our client based in Bern is seeking support for their Audit Team, an experienced Lead Auditor (6 - 12 month contract).Key Responsibilities:Conduct onsite audits and manage supplier qualification.Support Supplier Quality Management (SQM) processes, including SQM database.Assist with maintenance and clean-up of supplier...


  • Bern, Bern, Schweiz CSL Behring AG Vollzeit

    We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at CSL Behring AG. This role will play a crucial part in ensuring the quality of our products and processes.Job DescriptionThe successful candidate will be responsible for implementing and maintaining quality management systems, ensuring compliance with regulatory...


  • Bern, Schweiz CSL Behring Vollzeit

    CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In Bern, more than 1’800 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide. For our Bern site, we are currently looking for a **Project Operational Change Management Lead** This strategic project aims...

  • Quality Control Manager

    vor 6 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...


  • Bern, Schweiz CSL Behring AG Vollzeit

    As a Drug Product (DP) External Manufacturing Lead you will be responsible for providing process engineering support for all DP manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations (CMOs). You will be accountable for establishing and managing key process performance indicators across multiple CMOs, products and...


  • Bern, Schweiz CSL Behring AG Vollzeit

    As a Drug Product (DP) External Manufacturing Lead you will be responsible for providing process engineering support for all DP manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations (CMOs). You will be accountable for establishing and managing key process performance indicators across multiple CMOs, products and...


  • Bern, Schweiz Johnson & Johnson Vollzeit

    The Quality Excellence Director QA/QS, Advanced Therapies Platform, is responsible for delivering the Quality Assurance (QA) and Quality Systems (QS) platform strategy. This role will develop, execute, and monitor Advanced Therapies Quality (ATQ) projects, budget and strategies, and establish robust business and quality processes and systems to monitor...


  • Bern, Schweiz CSL Behring Vollzeit

    As a Drug Product (DP) External Manufacturing Lead you will be responsible for providing process engineering support for all DP manufacturing conducted on behalf of CSL Behring Operations at contract manufacturing organizations (CMOs). You will be accountable for establishing and managing key process performance indicators across multiple CMOs, products and...


  • Bern, Schweiz Johnson & Johnson Vollzeit

    For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the...