Associate Director, Quality Sterility Assurance
Associate Director, Sterility Assurance
Location: Pennsylvania (On-site)
About the Role
As the Associate Director of Sterility Assurance & Microbial Controls, you will be a key leader in establishing and sustaining the site's sterility assurance, contamination control, and microbial governance programs for a brand-new, state-of-the-art pharmaceutical manufacturing facility in Pennsylvania. This role requires deep technical expertise, strong leadership, and the ability to build programs, systems, and culture from the ground up.
You will serve as the primary Subject Matter Expert (SME) for aseptic operations, contamination control strategy, environmental monitoring, and microbial risk management - guiding facility design, qualification activities, and readiness for regulatory inspections.
Key Responsibilities
Leadership & Program Ownership
- Lead and develop a team of sterility assurance and microbiology experts.
- Establish and maintain the Microbial Controls Program, ensuring site-wide adherence to microbial risk standards.
- Serve as the SME for all matters related to sterility assurance, aseptic operations, and contamination control.
Contamination Control Strategy & Governance
- Author, own, and periodically review the Contamination Control Strategy (CCS) in partnership with MSAT.
- Lead, facilitate, write, and approve microbial risk assessments and contamination-related investigations.
- Front regulatory inspections for all CCS topics and sterility assurance programs.
- Oversee the development, qualification, and review of cleaning, disinfection, gowning, aseptic technique, and cleanroom behavior programs.
Facility & Process Build-Out
- Provide sterility assurance input during facility construction, layout design, HVAC strategy, cleanroom classifications, and material/personnel flows.
- Guide URS, FAT/SAT, and qualification activities for equipment affecting sterility and microbial control.
- Support new product, new process, and new equipment design through microbial review and risk assessments.
Aseptic Operations & Microbial Control
- Partner with Operations and QC to develop:
- Environmental Monitoring (EM) programs
- Utilities monitoring (WFI, compressed gases, HVAC systems)
- Gowning qualification programs
- Cleaning and disinfection programs supported by disinfectant efficacy studies
- Ensure disinfectants used at the site are robustly selected, qualified, and periodically reviewed.
Quality Systems, Investigations & Continuous Improvement
- Mentor contamination investigation teams to ensure high-quality, well-documented investigations and CAPAs.
- Critically analyze microbial data, author EM and utilities trending reports, and identify opportunities for system robustness improvements.
- Support and lead quality system activities (change controls, CAPA, QIPs) linked to sterility assurance and microbial controls.
- Participate in Quality Council and present microbial trends, risks, and improvement plans with cross-functional partners.
Training & Culture Development
- Partner with Training andSMEs to create and deliver training on:
- Microbial risk awareness
- Aseptic techniques
- Cleanroom behaviors
- Investigations and sterility assurance fundamentals
- Play a central role in building a site-wide aseptic culture and contamination prevention mindset.
Microbiology Modernization
- Drive strategy, qualification, and implementation of new microbiology technologies, such as rapid microbial methods and automation, aligned with global modernization initiatives.
Qualifications
Required
- Bachelor's degree in Microbiology, Biology, Life Sciences, Engineering, or equivalent.
- 8-12+ years of progressive experience in sterile/aseptic pharmaceutical manufacturing.
- Deep knowledge of FDA, EMA, EU Annex 1, and global aseptic/sterility regulatory expectations.
- Strong experience with contamination control, EM programs, aseptic processes, disinfectant qualification, and root cause analysis.
- Experience supporting new facility startups or major capital projects.
Preferred
- Advanced degree (MS, PhD) in a scientific discipline.
- Experience in biologics, vaccines, sterile injectables, or cell/gene therapy.
- Prior leadership/people management experience.
- Familiarity with RABS, isolators, and modern barrier technologies.
- Experience implementing rapid micro methods.
FAQs
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