Manager, Operational Support – GMP & Compliance Excellence

CSL Vifor; 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. You will drive compliance and operational excellence across deviation and change management, GMP-regulated manufacturing, and regulatory readiness.

You will collaborate with Manufacturing, Quality, Engineering, and other stakeholders to ensure reliable delivery of life-saving therapies while fostering a strong safety culture and continuous improvement.

Qualifikationen

• Bachelor's or Master's degree in Life Sciences, Biotechnology, Pharmacy, Engineering, Chemistry, or related discipline.
• Minimum 5 years of experience in a pharmaceutical/biotech/manufacturing environment.
• Strong experience in deviation management, change management, and GMP-regulated operations.
• Prior leadership experience or demonstrated ability to lead, coach, and develop employees is preferred.
• Fluent in German and English.

Aufgaben

• Lead, coach, and develop a team of Operational Support Scientists.
• Drive and ensure the effective execution of deviation management, change management, Right First Time initiatives and GMP compliance activities.
• Provide operational quality and compliance support to ensure stable, compliant 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 auditors.
• Identify and implement process improvements to enhance quality, compliance, reliability, and operational efficiency.
• Support the Facility Owner and facility leadership team through coordination of operational support activities and strategic initiatives.
• Foster a strong safety culture and ensure HSE compliance.

Kenntnisse

Deviation management

Change management

GMP operations

Operational Excellence

Leadership

Stakeholder management

Problem solving

German and English fluency

Ausbildung

Bachelor's or Master's degree in Life Sciences/ Biotech/ Engineering

Jobbeschreibung

CSL Behring in Bern is seeking a Manager Operational Support to lead a team of (Senior) Operational Support Scientists. You will drive compliance and operational excellence across deviation and change management, GMP-regulated manufacturing, and regulatory readiness.

You will collaborate with Manufacturing, Quality, Engineering, and other stakeholders to ensure reliable delivery of life-saving therapies while fostering a strong safety culture and continuous improvement.