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

Role Summary

Director/Senior Director, Global Process Owner for Sterility Assurance QMS, leading the global quality system requirements for Level 2 Aseptic Processing controls, including Aseptic Process Simulations, Barrier System Management, Cleaning and Disinfection, Aseptic Technique, and Aseptic Training. Provides strategic oversight for global Aseptic Processing Programs, drives standardization, and leads a cross-functional community of practice. Ensures inspection readiness and aligns Sterility Assurance program requirements with regulatory standards and industry practices.

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 and ensure they are designed according to regulatory, industry and company expectations.
• Provide governance, lead the implementations of 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 the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics.
• Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance.
• Monitor performance metrics, report and provide insights to inform decision making to drive further improvements.
• Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools.
• Actively collaborate with enterprise-wide teams on standardized global business processes.
• As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed.
• Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Aseptic Processing requirements inclusive of Aseptic Process Simulations, Aseptic Technique and Barrier system (e.g. Isolators/RABs) management.
• Provide overall guidance and leadership as related to Aseptic Process Simulation Program Design and Implementation, Aseptic Controls and Practices including Cleaning & Disinfection, Barrier System Controls, and Aseptic Technique.

Qualifications

• Required: 10+ years’ experience in the pharmaceutical industry in roles across commercial manufacturing and/or quality in a manufacturing, validation, and/or Quality roles supporting aseptic product manufacturing.
• Required: 7+ years’ experience in parenteral manufacturing sterility assurance control systems – development of systems, execution and operation of systems and continuous improvement of systems 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 a science and compliance perspective; up-to-date with developments in parenteral manufacturing (e.g., filling technology, contamination control, Annex 1 interpretation).
• Required: Strong written and oral communication skills.
• Required: Understanding of cGMPs, policies, procedures, and guidelines relating to sterility assurance.
• Required: Commitment to a safe work environment and supporting HSE goals.

Education

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

Additional Requirements

• Approximately 25% travel.