Associate Director, Head QA Compliance

1095 CSL Behring AG (CH); Bern; Ibrido; CHF 200.000 - 280.000; Tempo pieno

Descrizione del lavoro

CSL Behring is seeking a senior Associate Director, QA Compliance in Bern, Switzerland, to lead the site’s Quality Management System and ensure GMP compliance. The role partners with global quality teams to drive consistency and excellence across the network.

You will oversee quality governance, inspections readiness, risk management, and regulatory compliance, guiding a team of quality professionals and aligning with CSL standards and regulatory expectations.

Competenze

• Bachelor's degree or equivalent in a relevant scientific or technical discipline.

Mansioni

• Lead the implementation and ongoing ownership of the site's Quality Management System in accordance with CSL standards and global regulatory requirements.
• Chair the Site Change Control Panel and oversee Deviation Management, quality risk management processes, including maintenance of the Quality Risk Register.
• Lead site preparation for regulatory inspections, customer audits, self-inspections, and internal audit activities while driving continuous inspection readiness.
• Monitor and improve quality performance through KPI management, trend analysis, APRs, PQRs, and Quality Management Reviews.
• Provide leadership to quality teams and collaborate with Global Quality Systems and Compliance to standardise processes across the network.

Conoscenze

Quality governance

Leadership

Quality risk management

Change control

Deviation management

Audit readiness

Stakeholder management

Formazione

Bachelor's degree

Descrizione del lavoro

The Role Quality systems and regulatory compliance are fundamental to ensuring patients can depend on safe, effective medicines.

As Associate Director, QA Compliance, you will lead the implementation and continuous improvement of the site's Quality Management System, ensuring alignment with CSL standards and applicable GMP regulations.

This is a senior leadership role with broad responsibility for quality governance, inspection readiness, risk management, and regulatory compliance, while partnering closely with global quality teams to drive consistency and excellence across the wider network.

Location: Bern, Switzerland

Why It Matters

This role sits at the centre of the site's quality and compliance framework.

You will help ensure the ongoing effectiveness of the quality systems that support licensed manufacturing operations, maintain regulatory compliance, and safeguard inspection readiness.

Through leadership of quality risk management, change control, audit activities, and quality performance monitoring, you will play a key role in ensuring the site continues to meet the highest standards expected by health authorities, patients and the business.

What You'll Be Responsible For

As Associate Director, QA Compliance, you will provide strategic and operational leadership for site quality compliance activities while leading a team of quality professionals.

You will drive quality performance, oversee critical quality systems, and work across local and global functions to ensure consistent application of quality standards and continuous improvement initiatives.

Lead the implementation and ongoing ownership of the site's Quality Management System in accordance with CSL standards and global regulatory requirements.

Maintain site manufacturing and establishment licence requirements and ensure continued GMP compliance.

Chair the Site Change Control Panel and oversee Deviation Management, quality risk management processes, including maintenance of the Quality Risk Register.

Lead site preparation for regulatory inspections, customer audits, self-inspections, and internal audit activities while driving continuous inspection readiness.

Monitor and improve quality performance through KPI management, trend analysis, Annual Product Reviews (APRs), Product Quality Reviews (PQRs), and Quality Management Reviews.

Provide leadership and direction to quality teams while partnering with Global Quality Systems and Compliance colleagues to strengthen and standardise quality processes across the network.

Experience Required

Bachelor's degree or equivalent qualification in a relevant scientific or technical discipline.

Significant experience, typically 10+ years, in quality assurance, quality systems, compliance, or a related pharmaceutical manufacturing environment.

Deep expertise in pharmaceutical quality systems, quality management processes, GMP/GxP compliance, and regulatory requirements including ANNEX-1.

Demonstrated experience managing health authority inspections e.g. Swissmedic, US FDA, NMPA China etc.

associated regulatory interactions as well as customer audits.

Strong knowledge of quality risk management, change control, Deviation Management, quality performance monitoring, and continuous improvement methodologies.

Proven leadership, stakeholder management, and influencing skills, with experience working across global, matrixed, multicultural environments highly desirable.

Travel

Travel may be required to support collaboration with global quality and compliance teams, audit and inspection activities, and cross-functional initiatives across the network.

About CSL Behring

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

Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma.

Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are.

It fuels our innovation day in and day out.

By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

Equal Opportunity Employer CSL is an Equal Opportunity Employer.

CSL is an Equal Opportunity Employer.

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