Senior Director, Sterility Assurance – Global Quality Technical Operations

PCI Pharma Services

Sr. Director overseeing global Sterility Assurance operations to ensure compliance with industry standards.

Posted 5/24/2026full-timePhiladelphia • Pennsylvania • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact

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 the development and technical oversight of Site-Specific Contamination Control Strategies
Implement a stepwise bioburden reduction program for non-sterile manufacturing sites
Establish global standards for the sterile sampling and microbiological monitoring of clean utilities
Co-establish best practices with site Microbiology Labs
Evaluate and implement rapid microbiological methods and automated EM data collection tools
Standardize global programs for disinfectant efficacy testing and site-specific cleaning validation
Design and deploy comprehensive sterility assurance education and training programs
Train and mentor site Industrial Microbiologists
Oversee global programs for aseptic gowning qualification and media fill design

Requirements

What you’ll need

Bachelor’s degree in Microbiology, Biology, or a related Life Sciences discipline required
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 / , and ISO 14644 standards
Extensive experience in sterile fill-finish operations, lyophilization, and terminal sterilization
Leadership: Exceptional teaching and mentoring skills; ability to influence site-level culture and drive technical excellence

Benefits

Comp & perks

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

sterility assuranceaseptic processingcontamination control strategiesbioburden reductionmicrobiological monitoringdisinfectant efficacy testingcleaning validationrapid microbiological methodsautomated EM data collectionsterile fill-finish operations

Soft Skills

teaching skillsmentoring skillsinfluencing skillstechnical excellence