Associate Director - QC Environmental Monitoring

Role Summary

Associate Director - QC Environmental Monitoring responsible for oversight of environmental monitoring sampling operations, environmental monitoring laboratories, and FUME (utilities monitoring). Requires multitasking, strong communication, decision making, and problem-solving to anticipate and implement solutions.

Responsibilities

• Oversight of microbiology equipment commissioning and qualification.
• Provide administrative leadership of a diverse team including performance management and personnel development.
• Leverage the team through active engagement and delegation to achieve results.
• Manage a complex change agenda in a fast-paced environment.
• Manage multiple priorities and deliver by established due dates.
• Demonstrate flexibility with quick responses as priorities change or issues arise.
• Provide active communication on project status.
• Partner with production and design operation to ensure 24/7 support for required testing and monitoring against production schedule.
• Review and approve technical and GMP documents such as protocols, deviations, changes, summary reports, etc.
• Ensure safety in the lab and maintain a safe work environment, supporting all HSE goals.
• Establish connections with the Global Quality Lab Network and support global initiatives.
• Establish Lean Lab and efficient lab operations with processes for monitoring performance and continuous improvement.
• Define, lead and/or support inspection readiness activities for lab operations and interact with Regulatory agencies during inspections.

Qualifications

• Previous supervisory experience.
• 7+ years microbiology and/or environmental monitoring experience, including:
  • Demonstrated technical competency in Environmental Monitoring of traditional aseptic environments and isolators, including viable, non-viable, and personnel monitoring.
  • Demonstrated competency in Utility Monitoring (Process Air, Water for Injection, Clean Steam).
  • Deep understanding of compliance requirements and regulatory expectations.
• Ability to work 8-hour days, Monday through Friday; overtime as required; off-shift availability to respond to operational issues.
• Minimal travel required.

Education

• Bachelor of Science in Biology / Microbiology or related science.

Additional Requirements

• Tasks may require repetitive motion (e.g., keyboarding).
• Post-offer testing may be required.
• Work in various areas within the Parenteral Plant; consider allergens and mobility requirements.