Back to search
An established pharmaceutical manufacturer in the South East of England is seeking a senior sterility assurance professional to lead site-wide strategy across aseptic and sterile operations. This position plays a key role in ensuring regulatory compliance and driving best practice across contamination control, microbiology, and cleanroom operations.
Key Responsibilities:
-
Provide strategic leadership across all sterility assurance activities, including cleanroom compliance, environmental monitoring, aseptic process oversight, and microbiological quality systems.
-
Collaborate cross-functionally with QA, QC, manufacturing, and validation teams to embed sterility assurance best practices.
-
Lead and develop a team of microbiology and sterility professionals, driving continuous improvement initiatives across the site.
-
Oversee the qualification and ongoing compliance of aseptic areas, equipment, and utilities.
Ideal Candidate Profile:
-
Extensive experience in a sterility assurance, aseptic QA, or microbiology leadership role within a GMP-regulated pharmaceutical or biopharmaceutical environment.
-
Strong understanding of MHRA/FDA expectations relating to sterile product manufacture and contamination control.
-
Proven ability to lead cross-functional teams and influence sterility strategy across departments.
Sterility Assurance, Aseptic Manufacturing, Aseptic Assurance, Contamination Control, Cleanroom, Environmental Monitoring, GMP, MHRA, FDA, Quality Assurance, Pharmaceutical Manufacturing, Biopharmaceutical, Sterile Production, QA Manager, Microbiology Manager, Sterile Operations, Pharmaceutical Microbiology, Quality Systems, Aseptic QA, Sterile Fill Finish, Regulatory Compliance.
