Quality Control Laboratory Manager

QC Analytical Manager – Diagnostics | Berkshire

We're seeking an experienced and driven QC Analytical Manager to lead quality control and analytical operations in a fast-growing diagnostic manufacturing environment. If you have a strong background in ELISA-based testing, team leadership, and compliance within diagnostics or biopharma, this could be the ideal next step in your career.

About the Role

This leadership role sits at the heart of the QC and production function, overseeing a team of scientists and technicians responsible for testing, releasing, and continuously improving ELISA diagnostic kits. You’ll provide technical direction, manage resources, drive compliance, and ensure that products meet rigorous quality standards across the entire lifecycle – from raw materials to finished goods.

You’ll collaborate closely with R&D, QA, and Manufacturing teams to ensure process efficiency and product excellence, while also fostering a high-performing, quality-focused culture across your department.

Key Responsibilities

• Lead, mentor, and develop QC and Analytical teams
• Oversee testing of raw materials, antigens, conjugates, and final ELISA kits
• Ensure analytical data review, trending, and compliance with SOPs and regulatory standards
• Drive method validation, transfer, and troubleshooting
• Manage equipment calibration and qualification
• Lead investigations, audits, and CAPA implementation
• Develop and monitor KPIs, using data to improve performance
• Identify and implement process improvements (Lean, Six Sigma)
• Support regulatory readiness and continuous improvement initiatives

What We’re Looking For

• Degree in Biochemistry, Immunology, Biomedical Science, or related discipline (BSc or higher)
• 5–10 years’ experience in QC, manufacturing science, or diagnostics
• Experience/knowledge in ELISA/immunoassay lab environments - strongly desired
• Strong expertise in method validation, data integrity, and documentation compliance
• Skilled in statistical analysis tools (e.g. SoftMax Pro, Minitab, JMP)
• Experience supporting regulatory submissions and audit readiness
• Lean Six Sigma certification or equivalent process improvement experience
• Excellent problem-solving, communication, and team development skills

Apply Today

If you’re ready to lead from the front and make a measurable impact in diagnostic product quality, we’d love to hear from you. Apply now to bring your scientific leadership into a business that values innovation, quality, and people.