Head of Quality Control Microbiology

52389
  • Europe, United Kingdom
  • Contract
Head of Quality Control Microbiology

Key Responsibilities
  • Lead inspection readiness activities across the QC Microbiology function, identifying compliance gaps and driving remediation actions
  • Provide expert oversight of microbiological testing including raw materials, IPC, APIs, and environmental monitoring under GMP/GLP
  • Act as SME during internal and external audits, supporting inspections, preparing responses, and ensuring successful outcomes
  • Review and strengthen SOPs, training records, batch documentation, and quality system outputs to ensure full GMP compliance and data integrity
  • Drive continuous improvement initiatives across microbiology systems, contamination control strategies, and laboratory workflows
  • Provide senior scientific input into QC, Manufacturing, Validation, and Regulatory Affairs decision-making

 Candidate Profile
  • Degree in Microbiology, Biotechnology, Pharmacy, or related scientific discipline
  • Significant experience in QC Microbiology within GMP pharmaceutical or biotech environments
  • Proven track record supporting or leading regulatory inspections (EU GMP, FDA, MHRA, etc.)
  • Strong technical expertise in environmental monitoring, sterility assurance, bioburden, and contamination control
  • Deep understanding of cGMP, GLP, and global regulatory expectations
  • Ability to operate as a senior SME in inspection-driven, fast-paced environments
  • Strong analytical mindset with structured problem-solving ability

Contract Details
  • Senior contract assignment (inspection readiness focus)
  • Immediate start available
  • Mainly remote with 1–2 site visits per month
  • High-impact role supporting regulatory inspection preparation
  • Suitable for experienced QC Microbiology Heads, Senior SMEs, or Consultants

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