Sr. Director, Sterility Assurance – Global Quality Technical Operations

Responsibilities

Develop and execute a multi-year strategic roadmap for sterility assurance; Author and maintain global quality standards for aseptic processing and sterility operations; Establish a Global Sterility Assurance Center of Excellence; Lead development and technical oversight of Site-Specific Contamination Control Strategies ensuring compliance with EU GMP Annex 1; Implement a stepwise bioburden reduction program for non-sterile manufacturing sites; Establish global standards for sterile sampling and microbiological monitoring of clean utilities; Co-establish best practices with site Microbiology Labs for Environmental Monitoring and Personnel Monitoring; Evaluate and implement rapid microbiological methods and automated EM data collection tools; Standardize global programs for disinfectant efficacy testing and cleaning/sanitization validation; Design and deploy sterility assurance education and training programs; Train and mentor site Industrial Microbiologists as Shop Floor Champions; Oversee global programs for aseptic gowning qualification and media fill design; Provide expert technical consultation for capital projects; Serve as primary Subject Matter Expert for Sterility Assurance during regulatory inspections; 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; Supervises 1-10 employees

Requirements

Bachelor’s degree in Microbiology, Biology, or a related Life Sciences discipline required; Minimum 12-15 years of experience in Sterility Assurance or Industrial Microbiology within a GxP pharmaceutical environment; Proven expertise in EU GMP Annex 1, USP, 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; 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; Ability to Travel

Nice to have

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