Microbiology Associate Director

Job Description

The Associate Director, Quality Control (Microbiology, Incoming & Chemical Laboratory) provides strategic leadership and oversight of site Manufacturing Operations to ensure compliance with FDA regulations (21 CFR Parts 210, 211, and 820 as applicable), EU GMP, and ISO 13485 standards. The role oversees all testing activities related to microbiological control, raw material release, and chemical analysis, ensuring that systems, processes, and personnel support timely and compliant product disposition and regulatory readiness.

The Associate Director acts as a key member of the site quality leadership team, driving quality strategy, regulatory readiness, and continuous improvement initiatives aligned with global and site objectives, working collaboratively with Manufacturing, Supply Chain, EHS, Engineering, and other cross‑functional teams.

• Laboratory Oversight & Operations
  • Provide leadership and oversight for Microbiology Laboratory (environmental monitoring, sterility, bioburden, water testing), Incoming Materials Inspection and Testing, and 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, and 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, and 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
  • Ensure all laboratory activities operate within the Quality System, including Deviations, CAPAs, Change Control, and Risk Management (ICH Q9).
  • Serve as SME during Internal and external audits (FDA, EU, notified bodies) and 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 and 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, and a 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, and enhance microbiological control programs.
  • Identify and implement automation and digital solutions where appropriate.
  • Support site and global quality strategy alignment.

• Bachelor’s degree in…