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

Role Summary

The Director/Senior Director, Global Process Owner for Sterility Assurance (QMS) leads the global quality system for aseptic processing programs, including aseptic processing controls, simulations, barrier systems, cleaning and disinfection, aseptic technique, and training. They provide strategic oversight for global programs, manage a Program Community of Practice, drive key global projects, and ensure regulatory alignment and inspection readiness across the Sterility Assurance function.

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 (e.g., Process Simulations, Aseptic Technique, Barrier System management).
• Provide guidance and leadership 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 manufacturing, validation, or quality roles supporting aseptic product manufacturing.
• Required: 7+ years’ experience 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 including Aseptic Training, Aseptic Process Simulations, and Isolator Controls/Management.
• Required: Strong technical understanding of sterility assurance from science and compliance perspectives; current knowledge of industry developments (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 maintaining a safe work environment and supporting HSE corporate goals.

Skills

• Analytical and reporting capabilities with experience configuring and maintaining IT applications to support sterility programs.
• Strategic thinking with ability to execute decisions while balancing competing priorities.
• Change management and cross-functional collaboration, with experience leading matrixed teams.
• Strong governance and risk management capabilities, with ability to address quality/regulatory risks proactively.

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.