Manager Operational Support (m/f/x)

Job-Room; Bern; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

CSL Behring in Bern is seeking a Manager Operational Support to lead a team of (Senior) Operational Support Scientists and drive compliant, efficient manufacturing operations on Filling Line II. You will oversee deviation and change management, support regulatory compliance, audits, inspections, and cross-functional collaborations to deliver life-saving therapies.

This role emphasizes leadership, process improvement, and a strong safety culture within a GMP environment.

Qualifikationen

• Bachelor's or Master's degree in Life Sciences, Biotechnology, Pharmacy, Engineering, Chemistry, or related field.
• Minimum 5 years in a pharmaceutical/biotech manufacturing environment.
• Strong experience in deviation management, change management, and GMP-regulated operations.
• Experience in Manufacturing Operations, Quality Assurance, or Operational Compliance.
• Knowledge of aseptic manufacturing and EU GMP Annex 1 requirements strongly preferred.
• Prior leadership experience or demonstrated ability to lead, coach, and develop employees.
• Experience supporting audits, inspections, investigations, and cross-functional projects.
• Knowledge of filling, formulation, automated inspection, and/or packaging processes is an advantage.
• Hands-on experience with Operational Excellence and continuous improvement methodologies.
• Strong analytical, problem-solving, and stakeholder management skills.
• Fluent in German and English.

Aufgaben

• Lead, coach, and develop a team of Operational Support Scientists.
• Drive and ensure effective execution of deviation and change management processes.
• Provide operational quality and compliance support for stable manufacturing execution.
• Act as Subject Matter Expert for deviation and change management; support investigations and audits.
• Ensure timely review, approval, and closure of deviations, CAPAs, and change requests.
• Partner with Manufacturing, Quality, Engineering, and other stakeholders to address challenges.
• Promote inspection readiness and support interactions with auditors.
• Identify and implement process improvements to enhance quality, reliability, and efficiency.
• Support Facility Owner and leadership with coordination of operational activities.
• Foster a strong safety culture and ensure health, safety, and environmental compliance.

Kenntnisse

Leadership

Analytical skills

Stakeholder management

Problem solving

Operational Excellence

Continuous improvement

GMP compliance

Ausbildung

Bachelor's or Master's degree in Life Sciences or related field

Jobbeschreibung

CSL Behring is a global biotechnology leader driven by its promise to save lives. At our site in Bern, we develop and manufacture life‑saving therapies for people with serious and rare diseases around the world.

For our Filling Line II team within Manufacturing, we are looking for a motivated and experienced Manager Operational Support (m/f/x).

Manager Operational Support (m/f/x)

As Manager Operational Support, you will lead a team of (Senior) Operational Support Scientists and play a key role in ensuring compliant and efficient manufacturing operations within Filling Line II. Working closely with Manufacturing, Quality, Engineering, and other cross‑functional stakeholders, you will drive operational excellence by overseeing deviation and change management processes, supporting regulatory compliance, and contributing to the reliable delivery of life‑saving therapies to patients worldwide.

Responsibilities

• Lead, coach, and develop a team of Operational Support Scientists, fostering a collaborative and high‑performing work environment.
• Drive and ensure the effective execution of key compliance processes, including deviation management, change management, Right First Time initiatives, and GMP compliance activities.
• Provide operational quality and compliance support to ensure stable, compliant, and effective manufacturing execution.
• Act as Subject Matter Expert for deviation and change management processes and support investigations, audits, inspections, and facility‑related projects.
• Ensure timely review, approval, and closure of deviations, CAPAs, change requests, and related documentation.
• Partner with Manufacturing, Quality, Engineering, and other stakeholders to address operational challenges and drive business objectives.
• Promote inspection readiness and support interactions with internal, customer, and regulatory auditors.
• Identify and implement process improvements to enhance quality, compliance, reliability, and operational efficiency.
• Support the Facility Owner and facility leadership team through effective coordination of operational support activities and strategic initiatives.
• Foster a strong safety culture and ensure compliance with health, safety, and environmental requirements.

Qualifications

• Bachelor's or Master's degree in Life Sciences, Biotechnology, Pharmacy, Engineering, Chemistry, or a related scientific discipline.
• Minimum 5 years of experience in a pharmaceutical, biotechnology, or biologics manufacturing environment.
• Strong experience in deviation management, change management, and GMP‑regulated operations.
• Experience in Manufacturing Operations, Quality Assurance, Operational Compliance, or a related field.
• Demonstrated knowledge in aspectic manufacturing and EU GMP Annex 1 requriements is strongly preferred.
• Prior leadership experience or demonstrated ability to lead, coach, and develop employees is preferred.
• Experience supporting audits, inspections, investigations, and cross‑functional projects.
• Knowledge of filling, formulation, automated inspection, and/or packaging processes is an advantage.
• Hands‑on experience with Operational Excellence and continuous improvement methodologies.
• Strong analytical, problem‑solving, and stakeholder management skills.
• Fluent in German and English.

CSL is an Equal Opportunity Employer.

If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

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.

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. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

To learn more about CSL, CSL Behring, CSL Seqirus, and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.