Quality Control Manager; Lab Operations

Site Quality Control Manager (Laboratory Operations)

We are partnering with a global life sciences manufacturing organisation to appoint a Site Quality Control Manager to lead laboratory operations at a key production site in Escambia County, Florida.

This is a senior leadership role reporting directly to the Site Quality Head, with full ownership of the Quality Control organisation and laboratory value stream. You will play a critical role in ensuring batch release excellence, laboratory performance, and regulatory compliance, while driving continuous improvement across site operations.

This opportunity is ideally suited to an experienced QC Manager, Laboratory Manager, or Senior Quality Leader looking to step into a broader, site-level leadership role with high visibility and impact.

• Lead the Quality Control organisation, ensuring all raw materials, intermediates, and finished products meet defined quality standards
• Report into the Site Quality Head, acting as a key member of the site leadership team
• Own and enhance laboratory operations and batch review activities, ensuring compliance, efficiency, and reliability
• Drive a culture of continuous improvement, operational excellence, and right-first-time performance
• Partner cross-functionally across Manufacturing, Quality Assurance, and global teams to support product lifecycle and supply continuity
• Ensure the laboratory operates in a state of constant audit readiness in line with FDA and cGMP expectations

• Lead the site QC laboratory function, ensuring compliant testing, release, and batch review processes
• Deliver against safety, quality, cost, and delivery targets
• Act as a key quality voice within the organisation, ensuring standards are consistently met

• Own and strengthen the site Quality Management System (QMS) within the laboratory environment
• Drive improvements across CAPA, investigations, deviation management, and risk-based decision making
• Apply Lean, Six Sigma, and data‑driven methodologies to optimise performance

• Collaborate with site and global leadership to support
  • Process development and tech transfer
  • Operational and quality improvements
  • Change management activities
• Ensure quality is embedded into all critical business decisions
• Build and lead a high‑performing QC team, fostering accountability, engagement, and development
• Coach and mentor leaders and technical specialists within the laboratory
• Drive a culture of safety (psychological and physical) and continuous learning

• Optimise laboratory flow, capacity, and turnaround times
• Manage equipment lifecycle, qualification, and maintenance
• Oversee budgeting, capital expenditure, and resource planning
• Ensure robustness of critical systems, instrumentation, and materials
• Lead investigations and ensure effective resolution of quality events and laboratory deviations
• Track and report KPIs and performance metrics
• Identify and mitigate operational and compliance risks
• Represent the site in global quality and laboratory forums

We are seeking a hands‑on, strategic quality leader with:

• A Bachelor's degree in a scientific discipline (or equivalent experience)
• Strong experience in Quality, Laboratory Operations, or Manufacturing within:
  • Pharmaceuticals / Biopharma
  • Biotechnology
  • Medical Devices
  • Other regulated industries
• Leadership experience, managing QC or laboratory teams

• Strong knowledge of:
  • ISO 9001 / ISO 13485
  • FDA regulations, cGMP, CFR requirements
  • Core quality systems including CAPA, validation, audits, complaints, and risk management
• Experience with quality statistics, SPC, root cause analysis, and continuous improvement tools

• Proven ability to lead, develop, and scale teams
• Strong communicator able to influence at all levels
• Strategic mindset with a track record of delivering measurable business impact

• Analytical chemistry and/or microbiology in an ISO 17025 environment
• Experience with cleanroom, contamination control, or sterilisation processes (ISO 14644)
• Exposure to enterprise systems…