Director/Senior Director, Global Process Owner – Sterility Assurance QMS

Role Summary

Director/Senior Director, Global Process Owner – Sterility Assurance QMS. Establishes and maintains global quality system procedural requirements for Level 2 processes related to Aseptic Processing, provides strategic oversight for global Aseptic Processing Programs, leads a Program Community of Practice, and guides global projects within the Sterility Assurance program.

Responsibilities

• Establish and maintain the global quality system for Aseptic Processing Programs to drive standardization globally.
• Own the Global Standards, Processes, Practices, Trainings, and implementation tools; ensure design aligns with regulatory, industry, and company expectations.
• Provide governance, lead improvement initiatives, and foster a robust compliance mindset.
• Ensure processes are executed consistently and monitor signals for continuous improvement.
• Lead IT applications and analytical tools supporting reporting and analytics; ensure they are configured to meet business needs.
• Define global metrics to drive end-to-end performance and monitor performance; provide insights for decision making.
• Develop, lead, mentor, and maintain a community of cross-functional SMEs to collaborate on improvements.
• Collaborate with enterprise-wide teams on standardized global business processes.
• Ensure inspection readiness; interact with Health Authorities during inspections and draft responses as needed.
• Engage with external organizations to monitor regulatory policy changes and influence quality-related policies for Aseptic Processing.
• Provide guidance for Aseptic Process Simulation Program Design and Implementation, Aseptic Controls and Practices including Cleaning & Disinfection, Barrier System Controls, and Aseptic Technique.

Qualifications

• 10+ years in the pharmaceutical industry across commercial manufacturing or quality roles supporting aseptic product manufacturing.
• 7+ years in parenteral manufacturing sterility assurance control systems; development, execution, operation, and continuous improvement in a highly regulated environment.
• Bachelor‚Äôs degree in Natural Science, Engineering, Pharmacy, or related Life Science field.
• Experience implementing and leading global Sterility Assurance programs (Aseptic Training, Aseptic Process Simulations, Isolator Controls).
• Strong technical understanding of sterility assurance from science and compliance perspectives; up-to-date with industry developments.
• Strong written and oral communication; understanding of cGMPs and sterility assurance guidelines.
• Commitment to safety and HSE goals; approximately 25% travel.

Additional Preferences

• Experience leading multi-site/global functions improvement initiatives; matrixed organization leadership.
• Strategic thinking with ability to execute decisions amid competing priorities.
• Ability to analyze complex data to drive process improvements; change agility; excellent teamwork and communication skills.
• Expertise in scalable, standardized global processes; leadership with senior-level engagement.
• Governance development and risk management capabilities; people management experience.
• Experience navigating global regulatory standards; multisite standardization; oversight of aseptic processing programs and training.
• Collaboration with parenteral network TSMS group; inspection readiness support for new sites.
• Support establishment of a sterility assurance network or hub in global TSMS; support health authority inspections as an expert.

Education

• BS/MS in biological science or engineering (Microbiology preferred) or equivalent work experience.