Key Responsibilities:
● 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.
● 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.
● 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. .
● 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.
● 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.
●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
● 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
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