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Job Description
Who We Are Since 1990, we've grown into a global leader in personalized medicine. Today, our +5,000 energetic employees are based in +80 locations in Europe, North America, South America, Africa and Asia-Pacific and are working together to support over 200,000 customers worldwide. From compounding and natural products to software, equipment, and genomics — we deliver smart, ready-to-use solutions that make healthcare better. We're passionate, science-driven, and always looking for new ways to improve lives. Explore your future at Fagron Career Site. About the Job The Sterile Compounding Cleanroom Sr. Manager is responsible for the operational leadership, compliance oversight, and personnel management of ISO 7 sterile manufacturing and aseptic filling operations within a 503B outsourcing facility. This role provides direct oversight of sterile compounding, aseptic processing, cleanroom behaviors, and cGMP execution across all production shifts. The manager will serve as the primary operations leader within the cleanroom environment and is responsible for ensuring the facility maintains compliance with
FDA 21 CFR
Parts 210/211, USP <797>, applicable 503B outsourcing facility requirements, and internal quality standards. This position requires a strong hands-on presence within sterile manufacturing operations and the ability to lead teams in a fast-paced, highly regulated pharmaceutical environment. Key Responsibilities Sterile Manufacturing & Cleanroom Operations Provide leadership and oversight of ISO 7 sterile compounding and aseptic filling operations Maintain direct operational oversight of sterile filling, staging, filtration, line clearance, interventions, and cleanroom activities. Ensure all sterile manufacturing operations are executed in accordance with approved batch records, SOPs, and cGMP requirements. Monitor aseptic practices and personnel behaviors to ensure compliance with sterile processing standards. Partner with Quality Assurance, Microbiology, Engineering, and Manufacturing leadership to support compliant and efficient operations. Support media fills, aseptic process simulations, and process qualification activities. Drive continuous improvement initiatives related to sterile operations, cleanroom workflow, contamination control, and operational efficiency. Ensure proper escalation and response to manufacturing deviations, environmental monitoring excursions, sterility concerns, and compliance risks. cGMP & Regulatory Compliance Maintain compliance with
FDA 503B
outsourcing facility requirements, 21 CFR Parts 210 and 211, USP <797>, and applicable sterile manufacturing guidance documents. Support FDA inspections, customer audits, and regulatory interactions. Review and approve investigations, CAPAs, change controls, and quality events related to sterile operations. Ensure personnel adherence to gowning qualification, aseptic technique qualification, and cleanroom training programs. Promote a strong quality culture focused on patient safety, data integrity, and contamination control. Leadership & Personnel Oversight Provide leadership oversight for sterile manufacturing operations across all production shifts. Develop frontline supervisors, pharmacists, leads, and operators within the sterile manufacturing organization. Ensure staffing plans support production demands while maintaining compliance and operational readiness. Establish performance expectations, accountability standards, and operational metrics for the department. Operational Excellence & Metrics Track and report key operational and quality metrics related to sterile manufacturing performance. Drive reduction of manufacturing deviations, repeat events, and non-conformances through proactive operational oversight. Monitor trends related to environmental monitoring, visual inspection defects, sterility assurance, and aseptic interventions. Utilize metrics dashboards and data analysis to identify opportunities for process improvement and risk reduction. Basic Qualifications Required Qualifications Active Pharmacist license in good standing. Minimum of 5 years of experience in sterile compounding, aseptic manufacturing, or sterile pharmaceutical operations. Minimum of 3 years of leadership or supervisory experience within a cGMP-regulated environment. Demonstrated experience tracking manufacturing KPIs, quality metrics, and deviation reduction initiatives. Strong working knowledge of
FDA 503B
outsourcing facility regulations, aseptic processing principles, ISO classified cleanroom operations, USP <797>, environmental monitoring programs, and sterile filling operations. Ability to work cross-functionally with Quality, Engineering, Microbiology, Validation, and Manufacturing teams. Preferred Qualifications Experience in sterile pharmaceutical manufacturing or aseptic filling operations. Experience supporting FDA inspections and regulatory responses. Lean manufacturing or operational excellence experience. Physical & Environmental Requirements Ability to routinely gown and work within ISO-classified cleanroom environments for extended periods. Ability to stand, walk, and perform oversight activities within sterile manufacturing suites. Ability to wear required PPE and cleanroom gowning attire. Ability to support operational needs outside standard business hours when required. Leadership Competencies Strong leadership presence within manufacturing operations. High attention to detail and compliance mindset. Strong decision-making and problem-solving capabilities. Ability to lead in a fast-paced, highly regulated environment. Excellent communication and cross-functional collaboration skills. Commitment to patient safety and quality culture. What's on Offer? Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off. At Fagron, you'll find plenty of chances to grow — both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine. Ready for the challenge? We're proud to be an equal opportunity employer. Diversity makes us stronger, and we're committed to creating an inclusive workplace where everyone feels welcome. Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.
