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

Role Summary

Director/Senior Director, Global Process Owner for Sterility Assurance QMS. Leads the global quality system for aseptic processing, including process controls, simulations, barrier systems, cleaning and disinfection, aseptic technique, and training. Provides strategic oversight for global Aseptic Processing Programs, directs a Program Community of Practice, and leads key global Sterility Assurance initiatives. Uses deep expertise to educate facilities and ensure compliance with global regulatory requirements and industry standards.

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, ensuring alignment 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 analytical tools are configured and maintained to support business needs and enable accurate reporting and analytics.
• 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, lead, and mentor a community of cross-functional SMEs to collaborate on improvements and deepen knowledge of processes and tools.
• 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 and industry organizations to monitor regulatory changes and advocate for quality-related policies related to Aseptic Processing.
• Provide guidance on Aseptic Process Simulation Program design and implementation, Aseptic Controls and Practices including Cleaning & Disinfection, Barrier System Controls, and Aseptic Technique.

Qualifications

• Required: 10+ years in the pharmaceutical industry in roles across commercial manufacturing or quality in manufacturing, validation, and/or Quality roles supporting aseptic product manufacturing.
• Required: 7+ years in parenteral manufacturing sterility assurance control systems‚Äîdevelopment, 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 including Aseptic Training, Aseptic Process Simulations, and Isolator Controls and Management.
• Required: Strong technical understanding of sterility assurance from science and compliance perspectives; up-to-date with advances in parenteral manufacturing (e.g., filling technology, contamination control, Annex 1 interpretation).
• Required: Strong written and oral communication skills; understanding of cGMPs, policies, procedures, and guidelines related to sterility assurance.
• Required: Commitment to safe work environment and support of HSE corporate goals.
• Required: Approximately 25% travel.

Preferred

• Proven ability to work in a matrixed organization, leading diverse teams and influencing areas not under direct control.
• Experience leading a major multi-site or global functions improvement initiative.
• Strong strategic thinking with ability to execute decisions while balancing priorities.
• Experience addressing operational challenges with structured approaches and innovative solutions.
• Ability to drive process improvements and strategic decisions by analyzing complex data.
• Demonstrated change agility in leading others through change and ambiguity.
• Excellent teamwork, interpersonal, and communication skills across all levels.
• Expertise in developing scalable, standardized processes across global operations to reduce complexity.
• Leadership experience engaging with senior-level functional leads.
• Ability to balance speed, quality, and risk to deliver value-added business results.
• Experience establishing governance structures and proactively addressing quality and regulatory risks.
• People management experience.
• Expertise navigating global regulatory standards and frameworks.
• Experience leading multisite improvement initiatives or driving multisite standardization.
• Experience managing aseptic processing programs including global procedural requirements and training.
• Ability to work with senior technical staff to provide oversight to facilities and support inspection readiness and preparation.
• Support establishment of a sterility assurance network or hub in global TSMS.
• Support inspection preparation and execution during health authority inspections as an expert in Sterility Assurance.

Education

• BS/MS in a biological science (or equivalent work experience) or engineering discipline (Microbiology preferred, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.).