Senior Manager, Sterility Assurance
Location : North Carolina
Working Situation : Onsite
Level : Senior Level
Our client is a global healthcare company with a focus on treating kidney disease as well as other chronic and acute medical conditions.
We are actively seeking a senior level expert in aseptic sterilization operations to lead our microbiology lab while maintaining the sterility assurance program for manufacturing sites.
The successful Senior Manager, Sterility Assurance will be overseeing day to day operations as well as ensuring compliance and collaborating across teams for sterility assurance activities.
The Senior Manager, Sterility Assurance will be responsible for :
- Develop and execute strategies, policies, and procedures for microbiology labs and sterility assurance across the company's manufacturing facilities.
- Implement microbiology strategies for manufacturing facilities, covering environmental monitoring, microbiological testing, and microbial identification.
- Supervise daily operations of the microbiology lab, overseeing a team, scheduling testing, and ensuring timely product releases.
- Ensure compliance with FDA, EMA, PICs, USP, and ICH guidelines and industry standards.
- Manage sterile manufacturing operations, including cleanrooms, sterilization processes, and aseptic techniques.
- Lead a team in sterility assurance, offering guidance, training, and support.
- Conduct risk assessments and root cause analyses, implementing corrective and preventive actions.
- Foster relationships with cross-functional teams in manufacturing, quality control, and R&D to coordinate microbiology activities.
- Coordinate sterility assurance efforts with cross-functional teams.
- Participate in regulatory inspections, addressing inquiries and observations.
- Stay updated on industry trends and best practices in microbiology and sterility assurance.
The Senior Manager, Sterility Assurance will have the following qualifications :
- Bachelor's degree in microbiology, pharmacy, or biology; Master's or PhD preferred.
- Minimum 10 years' experience in microbiology, sterility assurance, aseptic processing, or related fields in pharmaceutical or biotech manufacturing.
- Strong knowledge of regulatory requirements and industry standards for sterile manufacturing, aseptic processing, and microbiology
- Excellent leadership, team management, analytical, and communication skills.
- Experience with regulatory inspections and audits preferred.
If you are interested in the Senior Manager, Sterility Assurance opportunity,
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