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

Role Summary

Director/Senior Director, Global Process Owner for Sterility Assurance Quality Management System (QMS). Leads global Aseptic Processing programs, establishes and maintains the global quality system for Level 2 sterility assurance processes, and drives standardization, compliance, and continuous improvement across the network. Builds and leads a program community of cross-functional SMEs, collaborates with global facilities, and ensures inspection readiness and regulatory alignment.

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 across the organization and monitor signals to drive continuous improvement.
• Act as leader and SME to ensure IT applications and analytics tools are configured and maintained to support business needs and reporting.
• Define global effectiveness and efficiency metrics to drive end-to-end performance.
• Monitor performance metrics, report insights to inform decision making and drive improvements.
• Develop and mentor a community of cross-functional SMEs to collaborate on improvements and deepen process/tools knowledge.
• Collaborate with enterprise-wide teams on standardized global business processes.
• Ensure inspection readiness as subject matter expert; interact with Health Authorities during inspections and draft responses 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, Aseptic Controls and Practices including Cleaning & Disinfection and Barrier System Controls.

Qualifications

• Required: 10+ years in the pharmaceutical industry across commercial manufacturing or quality roles supporting aseptic product manufacturing.
• Required: 7+ years in parenteral manufacturing sterility assurance control systems—development, execution, operation, and continuous improvement in a highly regulated environment.
• Required: Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.
• Required: Experience implementing and leading global Sterility Assurance programs (Aseptic Training, Aseptic Process Simulations, Isolator Controls/Management).
• Required: Strong technical understanding of sterility assurance from science and compliance perspectives; up-to-date with industry developments (e.g., Annex 1 interpretation).
• Required: Strong written and oral communication skills; understanding of cGMPs and related policies/guidelines for sterility assurance.
• Required: Commitment to a safe work environment and support for HSE goals.
• Required: Approximately 25% travel.
• Preferred: Ability to lead in a matrixed organization and influence cross-functional areas; experience leading multi-site/global improvements; strategic thinking with execution focus.
• Preferred: Proficiency in addressing operational challenges with structured approaches and innovative solutions; ability to analyze complex data for process improvements.
• Preferred: Change agility, strong teamwork and communication across levels; capability to develop scalable, standardized processes globally.
• Preferred: Leadership experience with senior functional leads; governance establishment; risk management in quality/regulatory contexts.
• Preferred: People management experience; experience navigating global regulatory standards; multisite improvement or standardization leadership.
• Preferred: Experience managing aseptic processing programs with global procedures and training; collaboration with TSMS groups for site oversight and inspection readiness.
• Preferred: Support for establishing a sterility assurance network or hub in global TSMS; participation in health authority inspections as an expert.

Education

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

Additional Requirements

• Approximately 25% travel.