Quality Control Manager

Main Purpose of Job

To lead the Quality Control function in a GMP laboratory analysing lipids and medicinal cannabis ensuring all analytical operational and compliance activities meet internal and regulatory standards including UK Home Office licence for controlled substances. The post holder will manage a specialist QC team oversee all GMP QC processes and contribute to the laboratorys strategy and planning.

The role requires significant autonomy exercising professional judgement in complex situations managing compliance and risk driving continuous improvement across QC operations and maintaining chain-of-custody integrity for controlled substances.

Main Duties of Postholder

1. Strategic & Departmental Contribution

• Contribute to QC strategy including method validation plans for lipids and cannabinoids audit readiness and process improvements.
• Identify operational and regulatory risks escalating high-impact issues to facility management.
• Support the strategic direction of business-critical QC projects.

2. Quality Control & Compliance

• Manage GMP testing for medicinal cannabis and lipid-based products including potency impurities residual solvents microbiology and stability.
• Maintain compliance with GMP ISO and Home Office controlled-substance regulations.
• Implement and maintain chain-of-custody procedures for controlled substances.
• Lead internal and external audits investigations and CAPA implementation.

3. Leadership & Resource Management

• Manage a QC team (analysts and technicians) including training development performance management and scheduling.
• Plan and oversee resource allocation instrumentation maintenance and qualification (GC GC-MS HPLC LC-MS/MS ICP-MS) and reagent management.
• Lead QC projects such as method validation and stability studies.

4. Problem Solving & Technical Leadership

• Troubleshoot complex analytical issues in lipid and cannabinoid matrices developing innovative solutions.
• Provide expert guidance on QC methodology instrumentation and data interpretation.
• Develop and implement continuous improvement initiatives for QC processes and documentation.

5. Stakeholder Management & Influence

• Collaborate with R&D QA regulatory agencies and external auditors.
• Represent the QC function in departmental meetings inspections and regulatory submissions.
• Communicate risk assessments analytical findings and remediation plans to facility management and external stakeholders.

6. Licensing & Controlled-Substance Management

• Ensure laboratory compliance with Home Office licence requirements for medicinal cannabis.
• Maintain meticulous documentation for controlled-substance handling storage and disposal.
• Train staff on licence compliance secure handling and chain-of-custody procedures.

Person Specification

Education/Experience/Skills

Essential

• Degree in Chemistry Biochemistry Pharmaceutical Science or related scientific discipline.
• DBS Enhanced Certificate for working with controlled drugs (or ability to obtain).
• Extensive experience in GMP QC laboratories preferably with lipids and medicinal cannabis.
• Demonstrated experience leading a QC team or specialist laboratory area.
• Experience in method validation stability studies and regulatory compliance (GMP ISO/UKAS).
• Proven record in managing controlled substances and chain-of-custody.
• In-depth knowledge of QC principles GMP ISO standards and controlled-substance regulations.
• Expertise in analytical techniques: GC GC-MS HPLC LC-MS/MS TLC UV and ICP-MS.
• Ability to interpret complex analytical data develop corrective actions and implement process improvements.
• Strong team leadership mentoring and performance management skills.
• Ability to plan prioritise and allocate resources effectively.
• Strong judgement and decision-making in complex time-sensitive situations.

Desirable

• Postgraduate qualification or professional certification in Quality Management GMP or ISO auditing.

Other Skills

• Strong organisational and project-management capability.
• Commitment to continuous improvement and innovation.
• Meticulous attention to detail and compliance in all laboratory operations.

Additional notes/Requirements

• Part of the facility is located up 1 flight of stairs with no lift access.

We will not consider the use of 3rd party recruitment agencies for the sourcing of candidates for this position.

The James Hutton Institute is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

The James Hutton Institute is a: Stonewall Diversity Champion; Athena SWAN Silver Status Holder; Disability Confident Committed Employer and a Living Wage Employer.

The James Hutton Institute is Happy to Talk Flexible Working.