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

Role Summary

Director/Senior Director, Global Process Owner – Sterility Assurance QMS is a leadership role within the Technical Service, Manufacturing Sciences, Sterility Assurance team responsible for establishing and maintaining global quality system procedures for Level 2 Sterility Assurance processes, including Aseptic Processing controls, training, and related programs along with global governance and strategic oversight.

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 improvements, and foster a robust compliance mindset.
• Ensure processes are executed consistently across the organization and monitor signals for continuous improvement.
• Lead IT applications and analytical tools to support reporting and analytics; act as SME for related systems.
• Define global metrics to drive end-to-end performance; monitor and provide insights for decision making.
• Develop and mentor a community of cross-functional SMEs; collaborate on improvements and deepen process knowledge.
• Collaborate with enterprise-wide teams on standardized global business processes.
• Ensure inspection readiness, interact with Health Authorities during inspections, and draft responses to observations as needed.
• Engage with external organizations to monitor policy changes and influence quality-related regulatory requirements for Aseptic Processing.
• Provide guidance on Aseptic Process Simulation Program Design and Implementation, Cleaning & Disinfection, Barrier System Controls, and Aseptic Technique.

Qualifications

• 10+ years in the pharmaceutical industry in roles across commercial manufacturing and/or quality supporting aseptic product manufacturing.
• 7+ years in parenteral manufacturing sterility assurance control systems‚Äîdevelopment, execution, operation, and continuous improvement in a highly regulated environment.
• Bachelor‚Äôs degree in Natural Science, Engineering, Pharmacy, or Life Science-related field.
• Experience implementing and leading global Sterility Assurance programs (Aseptic Training, Aseptic Process Simulations, Isolator Controls and Management).
• Strong technical understanding of sterility assurance from science and compliance perspectives; up-to-date with industry developments (e.g., Annex 1 interpretation).
• Strong written and oral communication skills; understanding of cGMPs and related guidelines.
• Commitment to safety and HSE goals; ability to travel ~25%.

Skills

• Strategic thinking with execution capability; ability to drive complex programs across multi-site/global functions.
• Change management, governance establishment, and risk management.
• Data analysis and interpretation to drive process improvements; proficiency with IT systems supporting Sterility Assurance.
• Leadership: able to guide, influence, and develop cross-functional teams; senior stakeholder engagement.
• Inspection readiness and experience with health authority interactions and responses.

Education

• BS/MS in biological science or engineering discipline (Microbiology preferred).