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 DescriptionThe 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.
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.
Our values
- PASSION
- CURIOSITY
- INTEGRITY
- BRILLIANCE
- RESPECT
Benefits
- 25 days holidays
- Life assurance & health allowance
- Discounts with local and national retailers
- Free 24/7 Employee Assistance Programme
- Recognition schemes and monetary awards
At LGC, we foster a culture of inclusion and collaboration. We believe that diverse perspectives lead to better outcomes and encourage applicants from all backgrounds to apply. We are an equal opportunity employer and offer reasonable accommodations to individuals with disabilities. If you require any adjustments throughout the recruitment process, please let us know.
Join us in this outstanding opportunity to be part of a company that is leading advancements in the industry!
All your information will be kept confidential according to EEO guidelines.
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Skills Required
- Bachelor's degree in chemistry, biochemistry, biological sciences, life sciences, or a related discipline, or equivalent education and relevant work experience.
- Experience managing Quality Management System processes, including CAPA, audits, deviations, non-conformances, change control, and document control.
- Experience managing people and guiding, developing, and motivating teams.
- Business partnering experience collaborating with leaders to improve performance, efficiency, and employee engagement.
- Strong knowledge of Quality Management Systems and ISO 9001 and/or ISO 13485 standards.
- Experience handling or supporting internal, customer, supplier, and regulatory audits.
- Understanding of root cause analysis and continuous improvement methods, such as 5 Why, 8D, and A3.
- Strong analytical, problem-solving, communication, organizational, and prioritization skills.
- Proficiency with Microsoft Office and quality metrics and trend analysis.
- Experience in ISO 9001 and/or ISO 13485 environments.
- Familiarity with FDA Quality System Regulations, including 21 CFR Part 820, and internal audit techniques.
- Lead Auditor certification.
- Experience with electronic Quality Management Systems, document management platforms, and ERP systems.
- Familiarity with EtQ and IFS.
LGC Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about LGC and has not been reviewed or approved by LGC.
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Healthcare Strength — Health, dental, and vision coverage with FSA/HSA options are consistently part of the package, and private medical is cited where applicable in the UK. Coverage is often characterized as solid alongside other core benefits.
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Retirement Support — Retirement offerings include a 401(k) with employer contribution in the U.S. and pension schemes in the UK, complemented by life and disability insurance. These elements are highlighted as part of a standard-to-competitive core package.
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Leave & Time Off Breadth — Paid time off, holidays, sick leave, and family leave are broadly available, with some sites offering a year‑end shutdown. Flexibility and local leave programs contribute to a generally well-rounded time‑off offering.
LGC Insights
What We Do
LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality and range. LGC’s tools play a key role in customer workflows from discovery applications through to commercial manufacture and enable its customers to: bring new diagnostics and therapies to market; progress research and development; optimise food production; and continuously monitor and enhance the quality of food, the environment and consumer products. LGC’s 175+ years of scientific heritage, combined with a track record of innovation and value-enhancing acquisitions, has enabled the company to build its product portfolio and expertise, and develop deep relationships with customers, industry partners and the global scientific community. LGC’s core purpose of Science for a safer world and its core values of passion, curiosity, integrity, brilliance and respect, drive its culture. As of 30 June 2021, it employs 4,350 employees, of which over 1,175 employees hold PhD and/or master’s degrees. Its products and services are delivered by highly qualified and experienced teams, operating from a global network of accredited sites that showcase its scientific and manufacturing capabilities.
