Senior Director Sterility Assurance

The Sr. Director, Sterility Assurance is a key technical leader within PCI Pharma’s global leadership team. This role is responsible for the strategic design and oversight of sterility assurance and contamination control frameworks across the global enterprise. As a peer to the Directors of Digital Transformation, Technical Operations, and eCompliance, this leader ensures that PCI’s manufacturing environments—ranging from high-complexity sterile fill-finish to non-sterile drug delivery—operate under the highest standards of microbiological control.

The Sr. Director will establish a Sterility Assurance Center of Excellence, providing the technical roadmap and training necessary to transform site-based industrial microbiologists into proactive shop-floor champions. This position strongly collaborates with MS&T, D&M Technical Operations, and Site Teams to ensure that sterility assurance is integrated into the design, validation, and daily operation of all PCI facilities.

Job Description

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Corporate Sterility Assurance Roadmap: Develop and execute a multi-year strategic roadmap for sterility assurance that aligns with PCI’s growth in advanced drug delivery and sterile manufacturing.
• Global Aseptic Standards: Author and maintain global quality standards for aseptic processing and sterility operations, ensuring harmonized practices across all sites that leverage industry best practices (e.g., PDA TRs, ISPE).
• Center of Excellence (CoE): Establish a Global Sterility Assurance Center of Excellence to serve as the central repository for technical expertise, troubleshooting, and innovation in microbiological control.
• Contamination Control Strategy (CCS): Lead the development and technical oversight of Site-Specific Contamination Control Strategies for all sterile facilities, ensuring compliance with EU GMP Annex 1.
• Non-Sterile Bioburden Reduction: Implement a stepwise bioburden reduction program for non-sterile manufacturing sites, focusing on risk-based environmental controls and prevention of objectionable organisms.
• Clean Utility Governance: Establish global standards for the sterile sampling and microbiological monitoring of clean utilities (WFI, Purified Water, Clean Steam, and Compressed Gases).
• Laboratory Standardization: Co-establish best practices with site Microbiology Labs for Environmental Monitoring (EM) and Personnel Monitoring (PM), ensuring data integrity and standardized incubation/identification protocols.
• Advanced Monitoring Technologies: Evaluate and implement rapid microbiological methods (RMM) and automated EM data collection tools in collaboration with the eCompliance and Digital Transformation teams.
• Disinfectant Qualification: Standardize global programs for disinfectant efficacy testing (DET) and site-specific cleaning/sanitization validation.
• Curriculum Development: Design and deploy comprehensive sterility assurance education and training programs for operators, engineers, and quality personnel.
• Microbiologist Development: Train and mentor site Industrial Microbiologists to serve as "Shop Floor Champions," moving the role from a laboratory-based function to an active, real-time presence in the manufacturing suite.
• Aseptic Technique & Behavior: Oversee global programs for aseptic gowning qualification and media fill (Process Simulation) design, focusing on the psychological and behavioral aspects of cleanroom discipline.
• Capital Project Support: Provide expert technical consultation for new builds and retrofits, ensuring facility design, airflow patterns (Grade A/ISO 5), and equipment sterilization (SIP/Autoclave) meet global regulatory expectations.
• Regulatory SME: Serve as the primary Subject Matter Expert for Sterility Assurance during high-stakes regulatory inspections (FDA, EMA, MHRA), defending CCS and sterility strategies.
• This position may require extra hours and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance to work is an essential function of this position
• Performs other duties as assigned by leadership.

Supervisory Responsibilities: Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

• Supervises 1-10 employees

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Education: Bachelor’s degree in Microbiology, Biology, or a related Life Sciences discipline required; Master’s degree or PhD in Microbiology preferred.
• Experience: * Minimum of 12-15 years of experience in Sterility Assurance or Industrial Microbiology within a GxP pharmaceutical environment.
• Proven expertise in EU GMP Annex 1, USP <797>/<800>, and ISO 14644 standards.
• Extensive experience in sterile fill-finish operations, lyophilization, and terminal sterilization.
• Track record of establishing global programs or Centers of Excellence.
• Leadership: Exceptional teaching and mentoring skills; ability to influence site-level culture and drive technical excellence through collaboration with MS&T and Global Engineering.
• Bachelor's Degree in a related field and/or 10 years related experience and/or training.
• College Level Mathematical Skills
• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.
• Ability to Travel

Preferred:

• Master's Degree (M.A.) in related field and/or 5 years related experience or training.
• Ability to work independently and/or part of a team.
• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems in a timely manner.