Sr Director, Microbiology

Job Description

Key Responsibilities:

Enterprise Strategy & Governance

● Establish and execute the enterprise microbiology and sterility assurance strategy aligned with corporate quality , manufacturing, and business objectives.

● Develop and maintain the global governance framework for microbiology, contamination control, and sterility assurance programs across all manufacturing sites and external manufacturing partners.

● Define global microbiological and sterility assurance standards, technical policies, procedures, and best practices to ensure consistent implementation throughout the organization.

● Serve as the executive subject matter expert and advisor to senior leadership on microbiological risk, contamination control, sterility assurance, and emerging regulatory expectations. .

● Drive enterprise initiatives focused on operational excellence, scientific innovation, and digital transformation within microbiology laboratories and contamination control programs.

Sterility Assurance & Contamination Control

● Provide strategic oversight of enterprise Contamination C ontrol S trategies (CCS) in accordance with EU GMP Annex 1 and global regulatory expectations. Establish scientific standards governing:

o Aseptic processing

o Sterile manufacturing

o Non-sterile manufacturing

o Biologics and biotechnology processes

o Cell and gene therapy operations

o Medical device and combination product manufacturing

o Water systems and clean utilities

o Facility cleaning and disinfection

o Sterilization technologies

● Provide technical oversight for cleanroom design, classification, qualification, airflow visualization, HVAC systems, personnel qualification, gowning programs, material and personnel flows, and facility contamination prevention.

● Ensure robust environmental monitoring, utility monitoring, aseptic process simulation (media fill), and contamination control programs are scientifically justified, risk-based, and global harmonized.

● Lead enterprise microbial risk assessments and contamination investigations for critical manufacturing events.

Laboratory & Technical Oversight

● Provide strategic oversight of enterprise microbiology laboratory operations, including: o Environmental M onitoring

o Sterility Testing

o Bioburden Testing

o Bacterial Endotoxin Testing

o Microbial Identification

o Mycoplasma Testing

o Antimicrobial E ffectiveness Testing

o Rapid Microbiological Methods

o Method Validation and Verification

o Microbiological Method Lifecycle Management

● Ensure laboratories programs maintain the highest standards of scientific integrity, data integrity, and regulatory compliance while promoting innovation through automation, advanced analytics, and emerging technologies. .

Quality Systems & Regulatory Compliance

● Ensure enterprise microbiology programs remain compliant with applicable FDA, EMA, MHRA, WHO, PIC/S, ICH, ISO, USP, EP, and other global regulatory requirements .

● Provide executive oversight for microbiology-related deviations, investigations, CAPAs, change controls, quality risk assessments, validation stra tegies, and technical justifications.

● Represent the organization during regulatory inspections, customer audits, due diligence activities, and health authority inspections. Provide microbiological expertise supporting regulatory submissions, product filings, responses to regulatory agencies, and post-marke t commitments.

● Monitor evolving r egulatory expectations and best practices, proactively implementing improv ements across the enterprise.

Investigation & Risk Management

● Lead scientific evaluation of significant microbiological events, contamination investigations, environmental monitoring excursions, sterility and aseptic processing simulation failures, utility excursions, and product impact assessments.

● Apply advanced scien tific principles and quality risk management methodologies to determine root cause , product impact and appropriate corrective actions.

● Establish enterprise microbial trending strategies utilizing statistical analysis and predictive analytics to identify emerging risks before product quality is impacted.

● Promote science-based decision making throughout the organization.

Cross-Functional Collaboration

●Collaborate with Global Manufacturing, Quality Operations, Facilities, Engineering, Validation, Technical Development, Supply Chain, Procurement, and Regulatory Affairs to:

o Support facility design and expansion projects

o Guide technology transfers

o Support new product introductions

o Improve manufacturing robustness

o Evaluate supplier microbiological controls

o Optimize contamination prevention strategies across the product lifecycle

Organizational Leadership

● L ead a world-class global microbiology organization focused on scientific excellence, operational performance, and continuous improvement.

● Develop technical capability through mentorship, coaching, succession planning, training programs, and technical development.

● Foster a culture of quality, accountability, innovation, and inspection read iness throughout the organization.

● Lead matrixed global teams and influence technical decision making across multiple business units and manufacturing sites.

Required Qualifications

● Bachelor’s degree with 14+ years of experience or PhD, MS, or equivalent advanced degree with 12+ years of experience in Microbiology, Molecular Biology, Biological Sciences, or related scientific discipline; S ignificant executive leadership experience desired .

● Minimum of 12+ years of progressive experience in pharmaceutical microbiology, sterility assurance, or contamination control within regulated pharmaceutical, biologics, biotechnology, or medical device environments.

● Extensive experience supporting glo bal sterile manufacturing operations and aseptic processing .

● Demonstrated expertise in :

o FDA , EMA, MHRA, WHO, and other global GMP regulations

o EU GMP Annex 1

o USP microbiology chapters

o ICH Quality Guidelines

o ISO microbiological standards

o Quality Risk Management (ICH Q9)

o Pharmaceutical Quality Systems (ICH Q10)

o Aseptic P rocessing

o C ontamination C ontrol Strategy development

● Proven success leading regulatory inspections and executive interactions with global health authorities. .

● D emonstrated leadership with large, complex, global matrixed organizations.

Preferred Qualifications

● Experience implementing Rapid Microbiological Methods (RMM) and microbiology laboratory automation.

● Experience supporting, ATMPs, cell and gene therapy, vaccines, biologics, or combination products.

● Board c ertification or professional certification through recognized microbiology or quality organizations.

● E xperience implementing digital laboratory platforms, predictive analytics, and data visualization tools.

● Lean, Six Sigma , O perational E xcellence, or equivalent continuous improv ement training .

Critical Competencies

● Executive leadership and influence

● Scientific and technical expertise

● Strategic vision

● Risk-based decision making

● Enterprise influence

● Business acumen

● Investigation and problem-solving capability

● Regulatory inspection readiness

● Change leadership

● Cross-functional collaboration

● Talent development and coaching

● Executive communication

● Innovation and digital transformation