Job Description

To provide QA oversight of the end-to-end product manufacturing process, ensuring compliance with pharmaceutical GMP, and Food and Feed quality standards; managing the shop floor quality team and batch release process, offering technical expertise, guidance, and leadership in all operational quality aspects.

Main Responsibilities:

Shop Floor Leadership

• Lead, coach, and mentor the QA operations team on the shop floor.
• Promote a strong quality culture, accountability, and right-first-time principles.
• Ensure effective QA presence and decision-making within production areas.

Technical Expertise

• Act as a subject matter expert for quality and compliance issues.
• Provide guidance to QA and production teams on complex quality challenges.
• Support troubleshooting and resolution of technical and process-related issues.

Regulatory Compliance

• Ensure full compliance with EU/UK pharmaceutical GMP regulations and food/feed safety standards.
• Monitor manufacturing practices to ensure adherence to approved procedures and regulatory requirements.
• Support regulatory inspections and external audits as required.

Batch Release

• Manage the batch release process, ensuring all products meet quality and compliance standards.
• Review batch manufacturing and packaging records for accuracy and completeness.
• Approve or reject product batches based on compliance with specifications and GMP requirements.

Non-Conformances and CAPA

• Lead and support investigations into deviations and non-conformances.
• Conduct root cause analysis and ensure effective corrective and preventive actions (CAPAs) are implemented.
• Track CAPA effectiveness and ensure timely closure.

Annual Product Quality Review (APQR)

• Manage and deliver the annual product quality review process.
• Analyse quality trends, deviations, complaints, and performance data.
• Identify improvement opportunities and ensure ongoing compliance with regulatory expectations.

Document Review and Approval

• Review and approve quality and technical documentation, including SOPs, specifications, validation protocols, and reports.
• Ensure documentation is accurate, compliant, and aligned with current regulatory and operational requirements.

Quality Metrics and Reporting

• Develop, monitor, and report KPIs related to quality performance.
• Use data analytics to identify trends, risks, and opportunities for improvement.
• Present quality performance updates to senior management.

Cross-Functional Collaboration

• Work closely with Production, Technical, Supply Chain, and Regulatory Affairs teams.
• Drive alignment on quality objectives and continuous improvement initiatives.
• Support new product introductions, process changes, and validation activities.

Training and Development

• Identify training needs and deliver targeted development programs for the QA team.
• Ensure all QA personnel are trained and competent in GMP and quality systems.
• Support ongoing professional development and succession planning.

Continuous Improvement

• Lead initiatives to improve quality systems, processes, and performance.
• Embed a continuous improvement mindset using structured problem-solving methodologies.
• Drive efficiency while maintaining compliance and product quality.

City

Lopen Head

State

Somerset

Location Country

United Kingdom

Skills & Abilities:

• In-depth knowledge of EU/UK GMP regulations and guidelines.
• Strong problem-solving and analytical skills.
• Excellent leadership and team management skills.
• Excellent communication and interpersonal skills.
• Detail-oriented with a focus on continuous improvement.
• Proven track record of maintaining high-quality standards in a GMP environment.
• Ability to handle multiple projects and priorities simultaneously.

Education & Experience:

• Bachelor’s degree in a related field
• Minimum 4 years’ experience in quality assurance or quality control in a pharmaceutical manufacturing environment, with 2 years’ experience in a management role
• Experience of HACCP preferred

About ADM

At ADM, we unlock the power of nature to provide access to nutrition worldwide. With industry-advancing innovations, a complete portfolio of ingredients and solutions to meet any taste, and a commitment to sustainability, we give customers an edge in solving the nutritional challenges of today and tomorrow. We’re a global leader in human and animal nutrition and the world’s premier agricultural origination and processing company. Our breadth, depth, insights, facilities and logistical expertise give us unparalleled capabilities to meet needs for food, beverages, health and wellness, and more. From the seed of the idea to the outcome of the solution, we enrich the quality of life the world over. Learn more at www.adm.com.