Section Manager

Key Responsibilities and Duties

Strategic Leadership and Compliance:

• Oversee and manage the site's Sterility Assurance program to ensure strict adherence to internal, global, and regulatory standards, including GMP, ISO, and FDA guidelines.
• Serve as the site's primary subject matter expert (SME) for all sterility assurance and microbiology-related matters during regulatory inspections and client audits.
• Develop and implement contamination control strategies and management plans to ensure continuous improvements in sterility and aseptic manufacturing.
• Lead and guide all aspects of aseptic processing, including but not limited to, environmental monitoring, media fills, smoke studies, and critical batch operations.
• Team and Process Management:
• Manage and mentor the Sterility Assurance team, providing clear direction, performance feedback, and professional development opportunities.
• Oversee the review and approval of critical documentation, including batch records, media fill/Aseptic Process Simulation (APS) protocols and reports, and validation documents.
• Lead and participate in all key investigations related to sterility assurance, adverse environmental trends, and product non-conformances, performing root cause analysis and implementing effective corrective and preventive actions (CAPAs).
• Develop and deliver comprehensive training modules on sterility assurance and aseptic techniques, ensuring all manufacturing and support staff are proficient in cleanroom behavior and best practices.

Risk Management and Improvement:

• Oversee the performance and approval of all risk assessments and mitigation plans concerning sterility assurance, including material and personnel movement within production and microbiology areas.
• Drive continuous improvement initiatives by analyzing data and trends from environmental monitoring, media fills, and other critical processes.
• Provide expert guidance on the microbiological and sterility aspects of change control and new product introductions, ensuring all changes are assessed for potential impact on product quality.
• Stay current with the latest industry regulations, technologies, and best practices in sterility assurance and microbiology to ensure the site's programs are always at the forefront of the industry.

Collaboration and Communication:

• Act as a liaison between the Sterility Assurance department and other cross-functional teams, including production, quality control, engineering, and quality assurance.
• Provide expert microbiological and sterility assurance expertise for all cGMP documents.
• Communicate critical issues to senior management and other stakeholders, providing recommendations and action plans to resolve potential risks.
• Manage departmental budgets and resources to meet operational goals and objectives.

Requirements

• Master's degree in Microbiology, Biology, or a related scientific field.
• Minimum of 10-15 years of proven experience in a cGMP-regulated industry, with at least 2-3 years in a leadership or managerial role focused on sterility assurance.
• Expert knowledge of aseptic processing, cleanroom operations, environmental monitoring, and contamination control.
• Extensive experience with regulatory inspections (e.g., USFDA, EMA) and a deep understanding of cGMP, ISO, and other relevant regulatory guidelines.
• Strong leadership, project management, and problem-solving skills, with a focus on root cause analysis.
• Excellent technical writing, verbal communication, and interpersonal skills.
• Proven ability to lead, mentor, and develop a team of professionals.