Manager Operational Support (mfx)

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

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

• Bachelors or Masters 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.

Interested in helping us deliver life-saving therapies to patients around the world We look forward to receiving your application.

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 worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

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.

To learn more about inclusion and belonging visit Opportunity Employer

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 Experience:

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