Lead, Sterility Assurance

Welcome to Catalent – an innovative pharmaceutical company dedicated to improving the health and lives of patients worldwide. We are currently seeking a highly motivated and experienced individual to join our team as the Lead of Sterility Assurance. In this role, you will play a critical role in ensuring the safety and quality of our products through the implementation and maintenance of sterility assurance processes. To be successful in this position, you must have a strong background in sterility assurance and cGMP regulations, as well as excellent leadership and communication skills. If you are passionate about making a difference in the pharmaceutical industry and have the necessary qualifications, we would love to hear from you. Join us at Catalent and be a part of our mission to deliver innovative and life-changing treatments to patients in need.

1. Develop and maintain sterility assurance processes and procedures in compliance with cGMP regulations.
2. Lead and manage a team of sterility assurance professionals, providing guidance and support to ensure the highest level of quality and safety in our products.
3. Conduct regular audits and inspections to identify and address any potential issues related to sterility assurance.
4. Collaborate with cross-functional teams to develop and implement strategies for continuous improvement of sterility assurance processes.
5. Stay up-to-date with industry trends and advancements in sterility assurance to identify opportunities for improvement and innovation.
6. Provide training and mentorship to team members to ensure a thorough understanding of sterility assurance processes and regulations.
7. Serve as the primary point of contact for regulatory agencies regarding sterility assurance matters.
8. Develop and maintain relationships with external stakeholders, such as vendors and suppliers, to ensure the quality and safety of materials used in our products.
9. Monitor and analyze data related to sterility assurance processes and communicate any potential risks or issues to upper management.
10. Collaborate with R&D teams to ensure the sterility of new product development processes.
11. Participate in the review and approval of sterility assurance-related documentation, such as protocols, reports, and SOPs.
12. Ensure compliance with all safety protocols and regulations in the handling and testing of sterile products.
13. Identify and implement cost-saving initiatives related to sterility assurance processes.
14. Represent the company in industry conferences and events related to sterility assurance.
15. Foster a culture of quality and continuous improvement within the sterility assurance team and across the organization.

According to JobzMall, the average salary range for a Lead, Sterility Assurance in Hanover, MD 21076, USA is $84,000 - $120,000 per year. However, this can vary depending on the specific company, industry, and level of experience of the individual. Other factors such as education, certifications, and job responsibilities can also impact the salary range.

Catalent, Inc. is a multinational corporation headquartered in Somerset, New Jersey. It is a global provider of delivery technologies, development, drug manufacturing, biologics, gene therapies and consumer health products. It employs more than 14,000 people, including approximately 2,400 scientists and technicians.