Director Sterility Assurance and Contamination Controls (69966)

Bachelor's degree in Chemistry, Microbiology, Pharmacy, Engineering, or another science-based discipline.

15+ years of experience in sterile/aseptic pharmaceutical manufacturing, microbiology, quality assurance, or quality compliance roles.

Experience leading in both matrix and functional environments with technical, operational, and people leadership responsibilities.

Extensive experience supporting health authority inspections, regulatory submissions, approvals, and lifecycle management.

Strong knowledge of audit and inspection management, investigations, complaints, and CAPA programs.

Deep aseptic processing expertise, including knowledge of isolators/RABS and Annex 1 requirements.

Experience supporting Environmental Monitoring (EM), Contamination Control Strategies (CCS), and process simulations.

Pharmaceutical quality manufacturing experience within sterile products, biologics, biosimilars, medical devices, or other highly regulated environments.

Strong understanding of cGMP requirements, quality systems, microbiology, quality control, quality assurance, and quality compliance.

Deep knowledge and experience in auditing, compliance, and quality oversight.

A recognized subject matter expert who can influence across a global organization.

A strong problem solver with excellent analytical and technical writing skills.

An effective communicator with strong presentation, collaboration, and negotiation skills.

Comfortable operating in a complex, global matrix environment.

Skilled in project management, prioritization, and change leadership.

Proactive, self-motivated, and committed to continuous improvement.

Able to navigate changing priorities while building strong partnerships across functions and cultures.

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