Engineering Compliance Manager in Wales

SERB is a fast-growing specialty pharmaceutical company that equips healthcare providers worldwide with life-saving medicines for patients facing rare conditions and emergencies. For over 30 years we have consistently provided emergency medicines, medical countermeasures, and the world’s leading portfolio of antidotes. Today SERB has over 500 employees in 18 countries and group revenue in excess of €400m. With a strong presence in the US, Europe, and the Middle East, along with a global network of trusted distribution partners, we make a broad range of essential medicines available in over 100 countries.

Having the right culture is as important to us as having the right portfolio. We are guided by our four values:

• We make patients our priority
• We act with accountability and integrity
• We work together as one team
• We look for better ways forward

By expanding our reach through selective acquisitions and entering new markets, we’re not just supplying medicine; we’re improving the standard of care for more patients around the world.

Broad Overview

The Compliance Engineering Manager will lead, manage and coordinate Quality related cGMP Engineering practices as aligned with our Quality Management System (QMS). To ensure that engineering expertise is provided to the site, maintaining Regulatory requirements and industry best practices at all times and ensure cGMP is consistently met. The Compliance Engineering Manager will further support our Asset Management system (Maximo), EHS, Calibration and SCADA systems. To play a key role in ensuring that our products meet the highest standards of quality and compliance.

Responsibilities

• Ensure Engineering QMS maintenance, in compliance with internal procedures and regulatory standards.
• Stay updated on industry trends and regulatory changes to ensure ongoing compliance and quality improvement within Engineering.
• Manage Engineering Quality compliance activities (Deviations, Change Controls, CAPA, RCA), ensuring timely execution of investigations, CAPAs, providing and gathering stakeholder input to support ongoing activities.
• Monthly reporting of quality performance metrics and planning of any corrective/preventative improvement opportunities.
• Carry out departmental periodic reviews and support document reviews, amendments, and creation. To ensure department SOPs are up-to-date and accurate with changes.
• Support the Engineering coordinator in the maintenance of the Maximo Asset Management system.
• Working with the Engineering Manager to support timely closure of unplanned maintenance requests.
• Support the operation and maintenance of the SCADA system. Ensure SCADA systems are properly integrated with production processes and quality control measures. Review SCADA data to identify trends, deviations, and areas for improvement.
• Lead initiatives in operational excellence to improve product quality and process efficiency.
• Collaborate with cross-functional teams to implement best practices and innovations in quality management.
• Responsible for Engineering cGMP Regulatory and EHS audit preparation and hosting.

Qualifications

• A dynamic goal-orientated professional.
• Project management aptitude.
• Excellent communicator at all levels.
• Must be able to work under pressure and co-ordinate several activities concurrently.
• Logical and numerate with an aptitude for detail.
• The ability to chair and present at meetings to ensure results are achieved.
• A keen strategic thinker who is willing to apply new concepts and ideas to take the business forward.

Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.