Join to apply for the Global Sterility Assurance Director role at Pauwels Consulting
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Join to apply for the Global Sterility Assurance Director role at Pauwels Consulting
Join a leading company in the pharmaceutical industry, where your skills will be essential in maintaining the highest standards of sterility assurance. This comprehensive role offers the opportunity to impact quality across multiple sites, ensuring compliance in a highly regulated environment.
As an ideal candidate, you are a knowledgeable Global Sterility Assurance Director ready to engage in collaborative partnerships to uphold stringent quality standards. You excel in building relationships and fostering teamwork while driving process improvements for enhanced aseptic capabilities.
* You facilitate interactions between Global sterility assurance and the contract manufacturing organizations (CMOs) under your responsibility.
* You act as the main point of contact for the CMO, supporting the implementation of the sterility assurance strategy.
* You oversee the establishment and execution of the annual Contamination Control Strategy.
* You guide the CMO in process confirmations and training related to sterility assurance.
* You conduct Key Performance Indicators analysis and perform gap assessments versus industry standards.
* You review the CMO’s annual performance in sterility assurance and assist with the preparation for future strategies.
* You lead external advocacy efforts, influencing trade associations to uphold sterility assurance standards.
What are we looking for?
* You hold a Bachelor’s degree in a Scientific Discipline.
* You have significant experience in an aseptic or bioburden control manufacturing environment, preferably in an FDA regulated setting.
* You possess in-depth knowledge of sterility assurance regulations and best practices.
* You have strong technical and quality skills specifically in sterility assurance.
* You demonstrate excellent coaching and mentoring abilities for shop floor training.
* You exhibit strong influencing capabilities and personal credibility within leadership teams.
* You easily network internally and externally, effectively communicating with a diverse range of partners.
* You are resilient and capable of adapting to different environments under pressure.
* You are proficient in English, both verbally and in writing.
Seniority level
* Seniority level
Director
Employment type
* Employment type
Full-time
Job function
* Job function
Other
* Industries
Staffing and Recruiting
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