Manager, Global Quality Affiliates and Logistics Operations (100%)

CSL Plasma; Bern; Vor Ort; CHF 100’000 - 130’000; Vollzeit

Zusammenfassung

A leading biotherapeutics company in Bern, Switzerland, is seeking a Manager for Global Quality Affiliates and Logistics Operations. In this role, you will ensure compliance in change control processes and manage quality assurance for logistics. You should have a strong background in Quality Management Systems and at least 5 years of experience in the pharmaceutical GxP environment. The ideal candidate must possess excellent communication skills and fluency in English, with additional languages being a plus.

Leistungen

Health and wellness programs

Qualifikationen

• Minimum 5 years in Quality Management Systems or Quality Assurance.
• At least 5 years of experience in change control within the pharmaceutical GxP environment.
• Fluency in English; additional languages beneficial.

Aufgaben

• Maintain a compliant Global Change Control system for logistics organizations.
• Support affiliates to ensure compliant change control processes.
• Manage deviations, CAPA, and improvement initiatives.

Kenntnisse

Communication skills

Collaboration skills

Computer literacy

Fluency in English

Ausbildung

University degree in a relevant scientific, logistics, or management field

Jobbeschreibung

As a Manager for Global Quality Affiliates and Logistics Operations, you will be responsible for maintaining a compliant Global Change Control system for the global logistics organizations in alignment with Global QMS. This includes hosting relevant change panels, providing training to Global Logistics Quality teams and stakeholders, and Affiliates for compliant completion of GCC activities. You will also support inspection readiness and monitor the GCC system through KPIs, acting as an SME in the global community of practice and GCC improvement initiatives.

You will support affiliates to ensure compliant change control processes as described above.

This role involves quality assurance for logistics processes, including:

1. Transport verification and compliance
2. Managing deviations, CAPA, and continuous improvement initiatives within CSL's global distribution network, including quality approval for GxP activities
3. Providing quality compliance support and oversight over distribution centers, contractors, and 3PLs/4PLs
4. Monitoring the quality system via KPIs, reports, and reviews
5. Escalating non-compliances according to global guidelines

The team acts as the single point of contact for logistics quality topics across CSL departments and business units.

You may deputize for team members or the supervisor as needed and are expected to undertake limited national/international travel.

Position Qualifications and Experience Requirements:

• University degree in a relevant scientific, logistics, or management field, or equivalent experience (minimum 5 years) in Quality Management Systems, Change Control, or Quality Assurance
• At least 5 years of experience in change control within the pharmaceutical GxP environment
• Strong communication and collaboration skills
• Computer literacy
• Fluency in English; additional languages like German, Spanish, or Portuguese are beneficial
• Limited travel required

Our Benefits

We prioritize your well-being. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a leader in biotherapeutics, committed to saving lives through innovative therapies in immunology, hematology, cardiovascular and metabolic, respiratory, and transplant areas. We leverage plasma fractionation, recombinant protein technology, and cell and gene therapy to address unmet medical needs.

CSL operates one of the largest plasma collection networks, CSL Plasma. Headquartered in Melbourne, Australia, CSL employs 32,000 people and serves over 100 countries.

We value diversity and inclusion

At CSL, inclusion and belonging are central to our mission. We foster a culture of curiosity and empathy to better serve our patients and stakeholders. Learn more Inclusion and Belonging | CSL.

Join us at CSL Behring and do work that matters!