Quality Manager
Role Overview
Our client is a world-leading specialist print and packaging manufacturer based in Bury St Edmunds, operating within a highly regulated environment. Driven by a culture of continuous learning and innovation, the business develops specialist solutions in direct response to customer needs and plays a critical role supporting pharmaceutical, healthcare, and medical customers, where compliance, traceability, and robust quality controls are non-negotiable.
They are now seeking an experienced Quality Manager to take full ownership of the Quality Management System and lead quality excellence across the business. This is a senior, hands-on role within a regulated print and packaging environment, requiring confidence in managing demanding customers, rigorous audits, and complex compliance requirements. The role also includes oversight of quality systems across three smaller group companies.
Key Responsibilities
* Own, maintain, and continually enhance the Quality Management System (QMS) in line with pharmaceutical and healthcare customer requirements.
* Ensure ongoing compliance with ISO 9001, ISO 14001, and other relevant regulatory and customer standards.
* Act as the primary quality interface for pharmaceutical and healthcare customers, managing technical queries, audits, and compliance expectations.
* Lead and host internal, customer, and third-party audits, ensuring a constant state of audit readiness.
* Manage deviations, non-conformances, CAPA, and lead effective root cause analysis.
* Maintain robust document control, traceability, and change management processes critical to regulated supply chains.
* Partner closely with production and operations to embed quality controls throughout the manufacturing process.
* Drive continuous improvement initiatives focused on risk reduction, compliance strength, and customer confidence.
* Support senior leadership in sustaining a strong quality culture aligned with regulated customer expectations.
* Produce quarterly quality and environmental performance reports for senior management.
* Ensure effective handover and knowledge transfer from the current Quality Manager ahead of retirement.
Skills & Experience Required
* Proven experience in a Quality Manager or senior quality leadership role within regulated manufacturing
* Degree in a relevant scientific, technical, or engineering discipline (e.g. Chemistry, Pharmaceutical Science, Packaging, Engineering)
* ISO 9001 Lead Auditor certification (essential)
* Strong working knowledge of GMP, GxP, and pharmaceutical/healthcare regulations
* Experience within print, packaging, or similarly regulated manufacturing environments.
* In-depth understanding of CAPA, deviation management, change control, and audit processes
* Hands-on, detail-driven approach with the authority to set and uphold quality standards
* Confident engaging with customers, auditors, and regulatory bodies
* Strong communication and stakeholder management skills
Personal Attributes
* Highly methodical, rigorous, and compliance-focused
* Calm, decisive, and proactive under pressure
* Customer-centric with a clear understanding of regulated client expectations
* Comfortable acting as the quality authority within the business
Why Join?
This is a rare opportunity to own and shape quality strategy within a respected, world-leading specialist manufacturer supplying high-profile pharmaceutical and healthcare customers. The role offers stability, autonomy, and real influence, with the opportunity to safeguard compliance, strengthen customer confidence, and drive operational excellence across the business.