Engineering Compliance Manager

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.

Your responsibilities include:

• 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.
• Assist in the preparation of the engineering and project budgets, ensuring investment activities support ongoing regulatory compliance and include investment in improvements required to maintain compliance.
• Input into the Regulatory strategies and author the relevant sections of Regulatory dossiers and submissions.
• When required, responsibility over engineering day-to-day, standing in for the Engineering manager.
• Carry out other reasonable tasks as required by the Line Manager.
• Ensuring that all interactions and engagements are carried out in accordance with Company values.

The above duties and responsibilities are not an exhaustive list, and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

To be successful in this role, you should demonstrate:

• A dynamic goal-orientated professional.
• 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.