Responsibilities: The Senior Manager QC Microbiology is responsible for leading and managing the Micro and Environmental Monitoring teams. This role involves setting goals, managing performance, and providing clear direction in line with company goals, with safety as the foundation of all activities.
The Senior Manager is the key contact for microbiology-related activities for the site and network and leads the team during regulatory inspections, ensuring network alignment on commitments prior to agreement with agencies. They ensure that quality and compliance requirements are executed as established in the site's SOP and corporate guidelines, providing necessary coaching and guidance. The role requires managing multiple competing priorities, including site and functional responsibilities, frequent communications, and attending meetings as lead microbiologist on site. Most importantly they provide environmental compliance oversight to support aseptic production activities.
Skills and Competencies:
• Oral and Written Communication: Excellent listening skills and strong presentation skills, with the ability to describe technical information effectively throughout the organization
• Adaptability: Ability to deal with frequent change, delays, and unexpected events
• Continuous Improvement: Innovative and resourceful, with a focus on continuous improvement
• Collaboration: Excellent team and interpersonal skills
• Problem Solving: Proven record of problem-solving and decision-making skills
• Science-Based: Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents
• Independent Decision Making: Exhibits sound and accurate judgment and knows when to escalate.
• Data Integrity: Strong knowledge and practices in data integrity
• Quality Management: Experience in managing and optimizing site EM Monitoring, Aseptic Technique training, and Gown qualification programs
• Regulatory Knowledge: Knowledge of safety, OSHA, and EPA regulations
• Technical Proficiency: Proficiency with Microsoft Word, Outlook, Excel, PowerPoint.
Qualifications:
• Education: Bachelor of Science degree in Microbiology, Biology or related science discipline
• Experience: Minimum of 10 years of related experience in GMP Aseptic or Sterile Manufacturing environment, working in Environmental Monitoring and/or Microbiology laboratory. Strong Environmental Monitoring management experience in a sterile manufacturing site is required. Knowledge of current trends in Aseptic Manufacturing standards and regulatory compliance requirements for Pharmaceutical/Biological manufacturing is preferred.
• Leadership: Demonstrated leadership and management skills, including establishing direction and goals, guiding execution, and fostering a team-based environment. Demonstrated mentoring and coaching, influencing, negotiating, and personal interaction skills.
Additional Information: The Senior Manager QC Microbiology plays a critical role in managing the QC Microbiology Release Testing and Environmental Monitoring laboratory. This department is responsible for testing products and monitoring the sterile manufacturing environment to ensure sterility assurance standards are met. The laboratory also supports New Product Introduction and Qualification activities related to manufacturing areas. The Senior Manager leads investigations, troubleshooting, and champions continuous improvement in their area.
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