Join IDEX Material Processing Technologies and be part of a team that provides specialist equipment & solutions for powder material handling & blending, particle size reduction, and liquid processing for the pharmaceutical, nutraceutical, food, and biopharmaceutical sectors. Here, you’ll collaborate with talented professionals from our globally recognized brands—including Quadro, Fitzpatrick, Matcon, and Microfluidics—who are dedicated to solving complex manufacturing challenges.
Our commitment to trust, teamwork, and excellence empowers every team member to contribute meaningfully to help our global customers. We celebrate diversity and inclusivity, ensuring that every voice is heard and valued. If you are passionate about creative problem-solving and want to make a real impact, come and discover a rewarding career with IDEX MPT, where every day is an opportunity to excel and drive positive change.
Site Quality Manager and Global Compliance Lea
Overall purpose of role:
The Site Quality Manager and Global Compliance Lead provides leadership for the site quality function and owns the effectiveness of the local quality management system, while leading global product and regulatory-systems compliance governance. The role has particular emphasis on equipment and solutions used in food, pharmaceutical, and nutraceutical applications. It ensures that products, processes, suppliers, technical documentation, validation activities, FAT protocol preparation and governance, and shipment release meet applicable customer, regulatory, industry, and internal requirements. Working across quality, engineering, operations, supply chain, project management, commercial, and service, the role reduces risk, strengthens customer confidence, improves first-pass quality, and builds a consistent culture of compliance and continuous improvement.
Key responsibilities:
Site quality responsibilities
- Lead the site quality function, including quality engineering, inspection and test, metrology, document control, nonconformance management, supplier quality, and quality-system administration.
- Own the site quality management system and ensure compliance with applicable ISO standards, customer requirements, regulatory obligations, industry expectations, and internal policies.
- Establish and manage site quality objectives, management reviews, improvement plans, and performance measures, including FAT first-pass success, on-time FAT readiness, punch-list closure, customer complaint recurrence, cost of poor quality, supplier defects, audit-action closure, and overdue compliance actions.
- Lead containment, root-cause analysis, corrective and preventive action, and effectiveness verification for significant product, process, supplier, field, and customer quality issues.
- Ensure inspection and test methods, acceptance criteria, calibration controls, quality records, and product-release processes are accurate, controlled, risk-based, and effective.
- Own the preparation, control, and approval of site FAT protocols and associated quality documentation, including defining acceptance criteria, aligning customer and regulatory requirements, coordinating cross-functional technical input, maintaining protocol templates, and ensuring approved protocols are available before FAT execution. Engineering and operations remain accountable for executing the FAT and recording the test results.
- Verify FAT protocol readiness before execution, review completed test records and deviations for conformity to the approved protocol, ensure punch-list items are assigned and closed, and withhold or escalate quality approval for product release or shipment where product, documentation, compliance, or acceptance requirements remain unmet.
- Own customer-quality planning and documentation, including pre-FAT agreement of protocol content and acceptance criteria, qualification support, complaint and field-quality escalation, and quality input to recovery plans for critical customer projects.
- Lead supplier quality controls, including supplier qualification and monitoring, audits, first-article and incoming inspection requirements, supplier corrective action, and traceability and certification for critical components and product-contact materials.
- Lead site internal, customer, supplier, and registrar audits and ensure findings and associated actions are closed effectively and on time.
- Partner with operations, engineering, supply chain, project management, commercial, and service teams to embed quality requirements into new product introduction, design and process changes, supplier management, production, FAT protocol development, installation, and field support.
- Develop the site quality team through clear accountability, coaching, training, performance management, capability building, and succession planning.
Global compliance responsibilities
- Establish and maintain the global product and regulatory-compliance framework, including policies, standards, governance, risk assessments, controls, reporting, and minimum requirements across applicable sites and business units.
- Monitor changes in applicable product, market, regulatory, industry, and management-system requirements; assess business impact; assign accountable owners; and coordinate timely implementation.
- Provide global governance for product conformity and market access, including CE marking and ATEX compliance where applicable, together with conformity assessments, technical files, risk assessments, declarations of conformity, certifications, labelling, restricted substances, product-contact material evidence, traceability, validation documentation, and customer-specific compliance requirements.
- Define and maintain risk-based requirements applicable to equipment used in Food, Pharmaceutical, and Nutraceutical applications, including hygienic and sanitary design, cleanability, product-contact materials, controlled test records, data integrity, qualification support, CE marking, ATEX requirements for equipment intended for potentially explosive atmospheres, and relevant FDA, GMP, and industry expectations where applicable.
- Define common compliance processes and minimum controls while partnering with site and functional leaders to ensure effective local execution and documented evidence of conformity.
- Lead or coordinate global compliance audits, assessments, and reviews; maintain visibility of findings and risks; and drive remediation actions through verified closure.
- Maintain global compliance dashboards and provide concise updates to senior leadership on regulatory changes, material risks, control effectiveness, trends, and overdue actions.
- Serve as the escalation point for significant product and compliance concerns, coordinating cross-functional containment, risk assessment, decision-making, documentation, customer communication, and lessons learned.
- Build global compliance capability through standardized training, guidance, tools, templates, and communities of practice.
- Demonstrated ability to lead a site quality organization while influencing global teams and senior stakeholders in a matrixed environment.
- Proficiency in FAT protocol preparation, document control, acceptance-criteria definition, and completed-record review, together with root-cause analysis, corrective and preventive action, process validation, change control, supplier quality, customer-quality planning, and quality performance analytics.
- Working knowledge of quality and compliance considerations for Food, Pharmaceutical, and Nutraceutical equipment, including hygienic design, cleanability, product-contact materials, traceability, qualification documentation, CE marking, ATEX conformity requirements, GMP expectations, and data integrity where applicable.
- Ability to interpret regulations, standards, specifications, customer requirements, and technical documentation and translate them into practical, scalable business controls.
- Strong judgement and decision-making, with the confidence to escalate risk, withhold quality approval, and drive timely accountability when requirements are not met.
- Clear, credible communication with employees, customers, suppliers, auditors, regulators, and senior leaders, combined with the ability to manage multiple priorities and lead cross-functional initiatives.
- Global product-compliance governance and risk management.
- Quality Management System ownership, auditing, and management review.
- FAT protocol preparation and governance, customer-requirement alignment, completed-record review, and quality-release decision-making.
- Customer, supplier, field, and regulatory issue management.
- Root-cause analysis, corrective action, and recurrence prevention.
- Continuous improvement and data-driven performance management.
- Cross-functional influence, sound judgement, and executive communication.
Knowledge:
- Strong working knowledge of quality management systems, product and regulatory compliance, risk management, audit practices, document control, validation, and product release.
- Strong progressive quality and compliance knowledge and experience in a regulated or highly controlled manufacturing environment, including evidence of experience leading people or a quality function.
- Demonstrated knowledge and experience preparing, controlling, and approving FAT protocols and reviewing completed FAT documentation, making product- or shipment-release decisions, managing customer and supplier quality, and supporting equipment used in Food, Pharmaceutical, or Nutraceutical applications is strongly preferred. Practical experience with CE marking, technical documentation, Declarations of Conformity, and ATEX compliance for applicable equipment is preferred.
- Experience working across multiple sites, regions, or global compliance process is also preferred.
Education and qualifications preferred:
Bachelor’s degree in Quality, Engineering, Science, Operations, or a related field required. Advanced degree and recognized quality, auditing, or regulatory certification are preferred.
Physical demands and work environment:
Combination of office and manufacturing-floor work, with regular interaction across production, engineering, project, and quality areas. International and domestic travel is required periodically to support global sites, FAT protocol alignment with customers, suppliers, audits, and compliance initiatives; frequency will vary according to business and project needs.
Location and any travel requirements:
Evesham site, Worcestershire, UK.
Global travel to customer and other manufacturing sites will be required, up to 25% of the time.
