GMP Operations Manager — Life Sciences & Compliance

CSL; Bern; Vor Ort; CHF 140.000 - 180.000; Vollzeit

Zusammenfassung

CSL Behring's Bern site seeks a Manager Operational Support to lead a team of Senior Operational Support Scientists and ensure compliant, efficient manufacturing on Filling Line II. You will drive deviation/change management, support regulatory compliance, and help deliver life-saving therapies worldwide.

The role requires 5+ years in biotech/pharma manufacturing, strong GMP experience, and leadership capabilities, with fluency in German and English.

Qualifikationen

• 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 requirements 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.

Aufgaben

• 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.

Kenntnisse

Leadership

Deviation Mgmt

GMP Compliance

Stakeholder Mgmt

German

English

Ausbildung

Bachelor's or Master's in Life Sciences, Biotechnology, Pharmacy, Engineering, Chemistry

Jobbeschreibung

CSL Behring's Bern site seeks a Manager Operational Support to lead a team of Senior Operational Support Scientists and ensure compliant, efficient manufacturing on Filling Line II. You will drive deviation/change management, support regulatory compliance, and help deliver life-saving therapies worldwide.

The role requires 5+ years in biotech/pharma manufacturing, strong GMP experience, and leadership capabilities, with fluency in German and English.