Company Description

With manufacturing sites across the US, UK, Germany and Denmark, LGC Biosearch Technologies has plans to continue growing. We deliver mission critical genomics to our diverse customer base in molecular diagnostics, pharma/biotech and agrigenomics. Our integrated portfolio of products, services and expertise supports our purpose of Science for a Safer World and we have embodied our mission by working with customers to enable research into life-altering treatment for disease and illness worldwide. We are currently seeking candidates who are up for the challenge of operating in a high-growth, purpose-driven organisation.

Job Description

The Manager, Quality Assurance, is crucial in leading our dedicated QA team and ensuring every product achieves high standards, customer satisfaction, and regulatory standards. This role is unique by providing an opportunity to operate in a dynamic environment where your contributions have a direct impact on our success and reputation.

To perform this job successfully, an individual must be able to capably perform each of the following essential duties:

• Oversee, manage, coordinate, lead, and prioritize quality assurance (QA) activities to guarantee adherence to ISO 9001, customer, regulatory, and quality management system (QMS) standards.
• Lead and develop the QA team by defining priorities and arranging daily tasks. Deliver mentoring, training, and performance evaluation. Promote a culture of quality, ownership, conformity, and ongoing progress.
• Coordinate product inspection, batch release, and disposition activities to guarantee products meet established quality, customer, and regulatory standards.
• Coordinate quality system processes such as document control, record management, CAPA’s, deviations, non-conformances, change control, supplier quality, management review, and audits, acting as the site’s Management Representative.
• Direct the establishment, execution, and continual advancement of the QMS by following quality performance statistics and reviewing quality data trends. Coordinate CAPA effectiveness and support quality aims. Explore ways to improve conformity and operational results.
• Direct internal, customer, supplier, and regulatory audit processes, acting as the chief contact for auditors, regulatory authorities, customers, and suppliers; manage audit responses, regulatory inspections, and ensure the swift closure of audit findings, CAPA’s, deviations, and non-conformances.
• Review and approve quality documentation, specifications, protocols, validation packages, technical reports, and quality records to guarantee alignment with internal and external requirements.
• Monitor, examine, and share quality performance metrics and crucial compliance indicators, providing regular updates and recommendations via management review processes.
• Lead continuous advancement projects by reviewing quality metrics, risk analyses, audit findings, customer insights, and operational performance patterns.
• Work closely with Operations, Quality Control, Supply Chain, customers, suppliers, and regulatory bodies to advance business goals, ensure quality standards, and maintain regulatory adherence.
• Provide leadership and subject matter expertise on quality systems, regulatory requirements, auditing, and industry guidelines, maintaining knowledge of ISO 9001, ISO 13485, and applicable FDA regulations.
• Perform other duties as required to support quality, compliance, operational, and business objectives.

Qualifications

ESSENTIAL KNOWLEDGE AND QUALIFICATIONS:

• Bachelor’s degree in chemistry, biochemistry, biological sciences, life sciences, or a related discipline or equivalent combination of applicable education and relevant work experience.
• Proven experience in managing QMS processes, including CAPA’s, audits, deviations, non-conformances, change control, and document control.
• Previous experience managing people, with the capability to guide, nurture, and inspire teams.
• Prior business partnering experience collaborating with leaders to find opportunities for improving performance, efficiency, and employee engagement.
• Strong knowledge of quality management systems and applicable standards such as ISO 9001 and/or ISO 13485.
• Experience handling or aiding internal, customer, supplier, and regulatory audits.
• Practical understanding of root cause analysis and continuous improvement methods (e.g., 5 Why, 8D, A3).
• Strong analytical, problem-solving, communication, and organizational skills, with the ability to prioritise various tasks and deliver quality outcomes.
• Proficient in Microsoft Office applications and the use of quality metrics and trend analysis to support decision-making.

Desired expertise and qualifications:

• Experience in ISO 9001 and/or ISO 13485 settings, familiarity with FDA Quality System Regulations (21 CFR Part 820) and internal audit techniques; Lead Auditor certification is an advantage.
• Strong knowledge of quality tools and methods, such as root cause analysis, corrective action procedures, training delivery, and organizational change management.
• Experience with electronic Quality Management Systems (eQMS), document management platforms, and ERP systems, with familiarity in EtQ and IFS preferred.