ADM
Quality Assurance Operations Manager
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We are seeking a QA Operations Manager to join our team onsite in Lopen. This role is critical in providing end-to-end quality assurance oversight across the manufacturing process, ensuring full compliance with pharmaceutical GMP and food/feed quality standards.
You will lead the shop floor QA team, oversee batch release, and act as a key technical authority—driving quality excellence, regulatory compliance, and continuous improvement across operations.
Key Responsibilities Leadership Lead, coach, and develop the QA operations team within manufacturing areas Foster a strong quality culture focused on accountability and right-first-time principles Ensure effective QA presence and real-time decision-making on the shop floor
Technical Expertise Act as a subject matter expert for quality and compliance Support teams in resolving complex quality and process-related challenges Provide hands-on guidance during troubleshooting activities
Regulatory Compliance Ensure adherence to EU/UK GMP and food/feed safety standards Monitor manufacturing practices against approved procedures Support regulatory inspections and external audits
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Batch Release Manage the batch certification and release process Review manufacturing and packaging records for completeness and accuracy Approve or reject batches based on compliance and specifications
Non-Conformances & CAPA Lead deviation investigations and root cause analysis Implement and track CAPAs to ensure effectiveness and closure
Annual Product Quality Review (APQR) Deliver APQR processes across product lines Analyse trends in deviations, complaints, and performance Identify and drive continuous improvement opportunities
Documentation & Quality Systems Review and approve SOPs, specifications, validation protocols, and reports Ensure documentation remains compliant and inspection-ready
Quality Metrics & Reporting Develop and track KPIs to measure quality performance Use data to identify risks and improvement areas Present insights to senior leadership
Cross-Functional Collaboration Partner with Production, Technical, Supply Chain, and Regulatory teams Support new product introductions, process changes, and validations
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Training & Development Identify skill gaps and deliver targeted QA training Ensure team competency in GMP and quality systems Support succession planning and career development
Continuous Improvement Lead initiatives to enhance quality systems and operational performance Embed structured problem-solving and efficiency improvements
Skills & Experience
Strong knowledge of EU/UK GMP regulations Proven leadership experience in a GMP-regulated environment Excellent problem-solving and analytical capability Strong communication and stakeholder management skills Ability to manage multiple priorities in a fast-paced setting
Qualifications Bachelor’s degree in a relevant scientific discipline Minimum 4 years’ experience in QA/QC within pharmaceutical manufacturing At least 2 years in a leadership or management role
Desirable Experience with HACCP and food/feed safety systems
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