Senior Director, Global Sterility Assurance

Band

Level 6

Job Description Summary

#LI-Remote

Location: Canada/Remote

Novartis will not offer relocation support for this role.

Are you ready to shape sterility assurance strategy with a strong North America regulatory focus while influencing manufacturing quality across the Novartis network As the Senior Director Global Sterility Assurance you will set sterility assurance and aseptic processing standards with primary accountability for aligning U.S. manufacturing operations to FDA expectations. Partnering closely with senior leaders across Quality Manufacturing Engineering and Technical Operations you will drive inspection readiness strengthen aseptic capabilities and guide complex cross-platform initiatives. This role blends deep technical expertise with enterprise leadershipprotecting product quality safeguarding patient supply in the U.S. and enabling consistent sterility assurance excellence globally.

Job Description

Key Responsibilities

• Lead sterility assurance strategy with primary focus on U.S. manufacturing and FDA regulatory expectations.
• Drive North America/U.S. inspection readiness and remediation programs partnering with sites to prevent repeat observations.
• Serve as Global Process Owner for Sterile Operations governing and harmonizing aseptic processes across platforms and sites.
• Provide proactive sterility assurance leadership during the design and qualification of new production facilities and microbiology laboratories ensuring that layouts processes and controls meet all relevant regulatory aseptic and quality compliance requirements.
• Serve as subject matter expert in microbiological topics leading resolution of sterility and contamination escalations.
• Lead complex cross-functional and cross-site projects delivering U.S. sterility assurance priorities and global quality initiatives.
• Monitor sterility assurance performance indicators and deliver clear executive-level insights to enable timely compliant decision-making.
• Represent Novartis externally as a recognized sterility assurance expert supporting U.S. industry engagement and global alignment.

Essential Requirements

• Bachelors degree in pharmacy chemistry microbiology or a related scientific discipline; advanced degree preferred.
• Minimum of 10 years of experience in global cross-disciplinary project management and leadership roles within the pharmaceutical industry preferably in strategic Site or global QA Operations and/or Compliance roles. Pharmaceutical production experience is indispensable.
• Extensive experience delivering sterility assurance leadership within U.S. pharmaceutical manufacturing and FDA-regulated environments.
• Deep technical expertise in microbiology aseptic processing and sterile manufacturing operations.
• Demonstrated success leading enterprise-level quality initiatives across multiple sites and manufacturing platforms.
• Proven ability to influence senior stakeholders lead cross-functional teams and drive complex high-impact programs.
• Travel up to 25%
• Language : French speaking and writing: Advanced. English speaking and writing: Advanced.

English language proficiency is required for this position due to the need to interact and participate in national and international meetings conducted in English and review scientific and strategic materials that are primarily available in English. These responsibilities are an essential part of the role and cannot be performed solely in French.

Skills Desired

Business Acumen Change Management Coaching Collaboration Communication Continuous Improvement Financial Acumen Leadership People Management Quality Assurance (QA) Quality Compliance Quality Management Quality Management Systems (QMS) Risk-Based Decision Making Risk Management Stakeholder Management Storytelling Strategic Thinking