Microbiology Associate Director

Job Description

The Associate Director, Quality Control provides strategic leadership and oversight of the site Manufacturing Operations to ensure compliance with the applicable regulations such as: FDA regulations (21 CFR Parts 210, 211, and 820 as applicable), EU GMP, and ISO 13485 standards.

The Associate Director, Microbiology, Incoming & Chemical Laboratory is responsible for providing strategic leadership, technical oversight, and regulatory compliance for microbiology, incoming materials testing, and chemical laboratory operations. This role ensures alignment with GMP, FDA, EU Annex 1, and global quality requirements while driving a robust contamination control strategy (CCS), data integrity, and laboratory excellence.

The position 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.

Works collaboratively with Manufacturing, Supply Chain, EHS, Engineering, and other cross-functional teams.

Job Responsibilities:

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

• 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)
  • 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.

Education and Experience:

• Bachelor’s degree in Microbiology, Chemistry, Biology, or related scientific discipline (Master’s or PhD preferred).
• 10+ years of experience in Quality/Laboratory functions within pharmaceutical manufacturing.
• Minimum 5 years in leadership roles overseeing laboratory operations.
• Strong expertise in:
  • Microbiology (environmental monitoring, water systems, sterility assurance)
  • Analytical chemistry and laboratory controls
  • Incoming material quality systems
• Proven experience supporting FDA inspections and regulatory responses.

Knowledge and Skills:

Technical Competencies

• Strong knowledge of:
  • GMP regulations (FDA, EMA, PIC/S)
  • USP and compendial requirements
  • Environmental monitoring and contamination control (Annex 1)
  • Method validation and laboratory systems
• Expertise in data integrity and computerized systems validation (CSV)

Leadership Competencies

• Strategic mindset with strong execution capability
• Ability to drive accountability and ownership across teams
• Strong decision-making based on risk and compliance considerations
• Ability to influence across all levels of the organization

Behavioral Competencies

• Results-driven with strong sense of urgency
• High level of organization and prioritization
• Strong collaboration and communication skills
• Ability to manage complexity and competing priorities
• Pharmaceutical experience is a must.

Physical Demands:

• Must be able to lift, push/pull, and carry up to 25 pounds
• Must be able to wear appropriate personal protective equipment as required
• Position requires sitting or standing for long hours
• Use of hands and fingers to manipulate office and calibration equipment is required