Microbiology Associate Director

Laboratory Oversight & Operations

• Provide leadership and oversight for: - Microbiology Laboratory (environmental monitoring, sterility, bioburden, water testing) - Incoming Materials Inspection and Testing - Chemical / Analytical Laboratory
• Ensure all laboratory testing is executed in compliance with GMP requirements (21 CFR Parts 210/211, ISO 13485, EU Annex 1).
• Ensure laboratories are adequately resourced, including staffing, equipment, and capabilities.
• Drive standardization, harmonization, and continuous improvement of laboratory practices across the site.

Microbiology & Contamination Control

• Act as the site SME for microbiology and contamination control.
• Ensure effective implementation and maintenance of the Contamination Control Strategy (CCS) in alignment with EU Annex 1.
• Provide oversight of: - Environmental Monitoring (EM) program - Water systems (PW/WFI) - Cleanroom qualification and control - Microbiological trending and investigations - Cleaning
• Ensure robust identification, trending, and mitigation of microbiological risks.

Incoming Material Control

• Ensure effective controls for incoming materials, including: - Sampling plans and testing strategies - Supplier qualification alignment with testing requirements - Risk-based material release processes
• Drive improvements in incoming testing efficiency while maintaining compliance.
• Ensure alignment between supplier quality programs and laboratory testing requirements.

Chemical / Analytical Laboratory Management

• Ensure compliance and robustness of analytical testing methods and lifecycle management.
• Oversee: - Analytical and Micro Method validation, verification, and transfer - Stability programs (if applicable) - Laboratory investigations (OOS, OOT, deviations)
• Ensure reliability and integrity of analytical data to support product quality and regulatory submissions.

Quality Oversight & Compliance

• Serve as SME during: - Internal and external audits (FDA, EU, notified bodies) - Regulatory inspections and responses (e.g., 483s, Warning Letters)
• Lead or support investigations with microbiological or analytical impact, ensuring scientific rigor and timely closure.

Data Integrity & Digital Systems

• Ensure ALCOA+ principles are embedded across laboratory systems.
• Oversee laboratory computerized systems (e.g., LIMS, analytical software) ensuring compliance with: - 21 CFR Part 11 - Data integrity requirements
• Support CSV lifecycle activities as applicable.

Leadership & Talent Development

• Build and develop a high-performing laboratory organization.
• Provide coaching and technical mentorship to microbiology and analytical teams.
• Foster a culture of: - Accountability and ownership - Urgency and execution - Quality mindset across all shifts
• Ensure appropriate technical expertise (e.g., microbiology SME presence) is in place.

Continuous Improvement & Strategy

• Drive initiatives to: - Improve laboratory cycle times - Strengthen investigation effectiveness - Enhance microbiological control programs
• Identify and implement automation and digital solutions where appropriate.
• Support site and global quality strategy alignment.