Senior Director, Global Sterility Assurance
RemoteMontréal, Quebec, Canada
Job Summary
Lead sterility assurance strategy with primary focus on U.S. manufacturing and FDA regulatory expectations. Drive North America 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 leadership during the design and qualification of new production facilities and microbiology laboratories. Monitor performance indicators and deliver 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. This role blends deep technical expertise with enterprise leadership to protect product quality and safeguard patient supply in the U.S. while enabling consistent sterility assurance excellence globally.
Required Qualifications
- Bachelor's degree in pharmacy, chemistry, microbiology, or a related scientific discipline
- Advanced degree
- Minimum of 10 years of experience in global, cross-disciplinary project management and leadership roles within the pharmaceutical industry
- Experience in strategic Site or global QA Operations and/or Compliance roles
- Pharmaceutical production experience
- 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%
- French speaking and writing: Advanced
- English speaking and writing: Advanced
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