Sterility Assurance Director

2 days ago


Pleasant Prairie, Wisconsin, United States BioSpace, Inc. Full time

Job Title: Sterility Assurance Director



We are seeking a highly skilled Sterility Assurance Director to join our team at BioSpace, Inc. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest standards of sterility assurance across our parenteral manufacturing sites.



Key Responsibilities:





  • Develop and implement sterility assurance strategies and initiatives to drive compliance and quality excellence

  • Collaborate with cross-functional teams to harmonize practices and drive consistency across the parenteral network

  • Provide technical expertise and support to sites and CMOs to ensure sterility assurance programs are robust and compliant

  • Lead investigations and root cause analyses to identify and address sterility assurance issues

  • Stay up-to-date with emerging regulatory guidance and industry trends to ensure Lilly's sterility assurance programs remain current and effective



Requirements:





  • 10+ years of experience in parenteral sterility assurance or equivalent roles

  • Deep technical understanding of sterility assurance from a science and compliance perspective

  • Proven track record of influencing site and network leaders to advance technical agenda projects

  • Strong written and oral communication skills, with ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology



About Us:



BioSpace, Inc. is a global healthcare leader dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. We are an EEO/Affirmative Action Employer and do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.



Why Join Us:



At BioSpace, Inc., we offer a dynamic and inclusive work environment that fosters growth and development. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. We are committed to making a positive impact on the lives of our employees and the communities we serve.



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