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We are seeking a highly skilled Sterility Assurance Director to lead our client, Pharmatech Associates, in Guadalajara, Mexico. With over 75 years of experience in the pharmaceutical industry, our client specializes in developing, manufacturing, and sterilizing complex medical devices and pharmaceutical products.
KEY RESPONSIBILITIES:
- Develop and drive contamination control and sterility assurance strategies for injectable products manufactured at the site.
- Collaborate with quality control, quality assurance, manufacturing, research and development, and regulatory affairs departments to ensure sterility concerns are integrated into all stages of the product lifecycle.
- Define and implement strategies for simulated filling programs, training and coaching of personnel, GEMBA-style assessments, process optimization, uniform usage strategies, site cleaning and disinfection programs, and validation procedures.
- Monitor and review microbiological data for trends, lead complex investigations, and establish preventative response plans to environmental events in cleanrooms.
- Interact with FDA and other regulatory agencies on all issues related to sterility assurance.
QUALIFICATIONS AND EXPERIENCE:
- Bachelor's Degree in a related field and 10 years of experience in a FDA-regulated environment.
- Previous leadership/management experience in the pharmaceutical/biotechnology industries.
- Practical experience in aseptic manufacturing operations, microbiology laboratory operations, contamination control programs, and engineering controls for clean room operations.
