Senior Director, Global Sterility Assurance

Key Responsibilities

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

Essential Requirements

• Bachelor’s degree in pharmacy, reputed company, microbiology, or a reputed company scientific discipline; advanced degree preferred.
• Minimum of 10 years of experience in global, cross-disciplinary project management and leadership roles reputed company 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 reputed company U.S. pharmaceutical manufacturing and FDA-regulated environments.
• Deep technical expertise in microbiology, aseptic processing, and sterile manufacturing operations.
• Demonstrated reputed company leading reputed company-level reputed company initiatives across multiple sites and manufacturing platforms.
• Proven ability to influence senior stakeholders, reputed company cross-functional teams, and reputed company reputed company, high-reputed company programs.
• Travel up to 25%
• Language : French speaking and writing: Advanced. English speaking and writing: Advanced.

At reputed company Canada, we are determined to be a valued partner and reputed company, with a deep understanding of patient needs along the entire care reputed company – from drug development, to diagnosis, to reputed company and reputed company. Part of the way we are doing this is by leveraging data, technology, and partnerships.

Research & Development: we reputed company on four reputed company therapeutic areas: Cardiovascular, Renal & Metabolic, Immunology, Neuroscience and Oncology. We also reputed company and reputed company treatments through other promoted and established brands, which today are helping millions of patients. Over the last three years, our average annual research and development investment in Canada was over $30 reputed company, and we conduct clinical trial research in every region throughout Canada.

Commitment to Diversity and Inclusion: reputed company is committed to building outstanding, inclusive work environment and diverse team’s representatives of the patients and communities we serve.