The role
03As 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.
01Lead, coach, and develop a team of Operational Support Scientists, fostering a collaborative and high-performing work environment.
02Drive and ensure the effective execution of key compliance processes, including deviation management, change management, Right First Time initiatives, and GMP compliance activities.
03Provide operational quality and compliance support to ensure stable, compliant, and effective manufacturing execution.
04Act as Subject Matter Expert for deviation and change management processes and support investigations, audits, inspections, and facility-related projects.
05Ensure timely review, approval, and closure of deviations, CAPAs, change requests, and related documentation.
06Partner with Manufacturing, Quality, Engineering, and other stakeholders to address operational challenges and drive business objectives.
07Promote inspection readiness and support interactions with internal, customer, and regulatory auditors.
08Identify and implement process improvements to enhance quality, compliance, reliability, and operational efficiency.
09Support the Facility Owner and facility leadership team through effective coordination of operational support activities and strategic initiatives.
10Foster a strong safety culture and ensure compliance with health, safety, and environmental requirements.
