Senior Manager – External Supply Quality Assurance

CSL; Bern; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

CSL is seeking an experienced Quality leader to oversee External Supply Quality Assurance for contract manufacturers in Bern and Marburg. The role focuses on strategic quality oversight, robust systems, and reliable product supply across CMOs.

You will lead a small international team, manage complex quality issues, support regulatory inspections and drive standardization across the external network with an emphasis on sterile manufacturing and EU GMP Annex 1 compliance.

Qualifikationen

• University degree in a relevant scientific, technical or business discipline.
• Minimum of 8 years in a GxP-regulated pharmaceutical environment.
• Strong GMP manufacturing experience in sterile production.
• Knowledge of EU GMP Annex 1 and regulatory expectations.

Aufgaben

• Lead an international team of three Quality professionals in Bern and Marburg.
• Provide strategic Quality oversight for CMOs and ensure robust systems.
• Manage complex quality issues, investigations and CAPAs.
• Monitor KPI performance and drive corrective actions.

Kenntnisse

GxP compliance

CMO management

Sterile manufacturing

EU GMP Annex 1

Quality leadership

Regulatory inspections

Stakeholder management

Change management

Team leadership

Quality systems

Ausbildung

University degree in science/engineering

Jobbeschreibung

Innovative and committed to patients worldwide.

CSL is a global biotechnology leader committed to developing and delivering innovative medicines that improve the lives of patients with serious and rare diseases around the world.

For our External and Supply Quality organization, we are looking for an experienced Quality leader to join us as

Senior Manager, External Supply Quality Assurance (100%) (m/f/d)

In this role, you will provide strategic Quality oversight for our Contract Manufacturing Organizations (CMOs) across the region and lead a small international team based in Bern and Marburg. You will act as a key Quality partner to our external manufacturing network, ensuring robust quality systems, reliable product supply and consistent application of CSL Quality requirements.

Combining strong expertise in sterile pharmaceutical manufacturing and EU GMP Annex 1 with people leadership and strategic thinking, you will manage complex quality topics and escalations, monitor CMO performance and build strong relationships with our external partners. You will also represent Quality in business reviews, cross-functional initiatives and regulatory activities and support the continued development of our external manufacturing network.

Responsibilities

• Lead, coach and develop an international team of three Quality professionals based in Bern and Marburg, providing clear direction and supporting effective collaboration across the external supply network.
• Act as a senior Quality interface for CMOs, establishing collaborative relationships with external manufacturing partners and relevant internal stakeholders to ensure effective Quality oversight, robust quality systems and reliable product supply.
• Manage complex CMO quality and reliability issues and escalations, providing strategic and technical guidance and ensuring appropriate investigation, remediation and corrective actions.
• Monitor and evaluate CMO Quality performance through globally aligned KPIs, identify recurring trends and ensure effective corrective and preventive actions are implemented.
• Oversee and support the standardization of CMO Quality Agreements, ensuring appropriate alignment with the corresponding commercial agreements.
• Drive consistent Quality oversight and governance processes across CMOs and CSL sites, including Change Management, deviations, complaints, Batch Record Reviews, recalls and other relevant Quality processes.
• Represent CSL Quality in Joint Business Review Meetings and other governance forums, lead Quality-related discussions with CMO partners and support the preparation of relevant steering and decision-making materials.
• Provide on-site Quality support at CMOs when required, including support for Quality maturity initiatives, remediation roadmaps and regulatory observations related to CSL products.
• Represent Quality in cross-functional initiatives involving CMO Operations, technology transfers, process improvements and other external manufacturing activities.
• Support CSL product-related regulatory inspections at CMOs and contribute to regulatory, corporate and self-inspections, assessing potential Quality and supply impacts and supporting appropriate follow-up activities.
• Manage the Quality intake of new CMO projects and initiatives, including support for CMO selection, due diligence assessments, Quality risk evaluations and assessment of the resources and capabilities required for successful execution.
• Maintain awareness of new and evolving regulatory requirements and industry trends, particularly those affecting sterile manufacturing and external supply, and translate these into appropriate Quality oversight activities.
• Build and maintain effective relationships across the Global Quality organization and wider cross-functional network, influencing stakeholders and driving alignment in a complex global matrix environment.
• Act as delegate for the Head of CMO Quality when required, supporting business continuity and contributing to the broader External and Supply Quality strategy.

Qualifications

• University degree in a relevant scientific, technical or business discipline, or an equivalent combination of education and relevant professional experience.
• Minimum of 8 years of experience in a GxP-regulated environment within the pharmaceutical industry.
• Strong hands-on GMP manufacturing experience in a sterile/aseptic production environment.
• In-depth knowledge and practical understanding of EU GMP Annex 1 requirements and their application within sterile pharmaceutical manufacturing.
• Strong understanding of relevant pharmaceutical regulations and Quality requirements, including European and international regulatory expectations.
• Broad knowledge of pharmaceutical Quality Systems, including deviations, CAPAs, Change Management, complaints, batch documentation and inspection readiness.
• Experience working with CMOs, external manufacturing partners and/or external supply networks is highly desirable.
• Proven people-management and leadership experience, with the ability to lead, coach and develop employees across different locations.
• Demonstrated ability to manage complex Quality issues and escalations, make sound risk-based decisions and drive sustainable resolution with internal and external stakeholders.
• Strong strategic thinking and business acumen, with the ability to understand broader business and supply implications while maintaining appropriate Quality and compliance standards.
• Excellent stakeholder-management, negotiation and influencing skills, including the confidence to navigate challenging discussions with senior internal stakeholders and external partners.
• Experience operating effectively in a global matrix organization and collaborating across functions, regions and organizational levels.
• Strong change-management mindset and ability to drive standardization and continuous improvement across complex external networks.
• Fluent English, both written and spoken; German language skills are highly desirable.

About This Position

• This is a senior Quality leadership position combining people management, technical Quality expertise and strategic oversight of external manufacturing partners.
• A particular focus of the role is the Quality oversight of sterile manufacturing activities. Strong practical experience in a sterile GMP production environment and a sound understanding of EU GMP Annex 1 are therefore essential to successfully challenge, support and partner with our external manufacturers.
• Beyond day-to-day CMO Quality oversight, you will contribute to the continued development of our external manufacturing network through performance governance, standardization, due diligence, new projects and strategic Quality initiatives. As delegate for the Head of CMO Quality, you will also support continuity of leadership and decision-making across the organization.