Quality Manager

JOB TITLE: Quality Manager

LOCATION: Belfast 

INDUSTRY: Pharmaceutical

SALARY: £60,000 - £65,000 per annum 

HOURS OF WORK: Monday - Friday Day Shift 

Overview

In Partnership with our Client, we are recruiting for a Permanent Quality Manager. This is an amazing time to join this team as they embark in their expansion based at their brand new and first premises in Northern Ireland. 

The appointed person will provide senior management support to all Quality Assurance and Validation staff and functions as well as ensuring all aspects of Quality Management are following EudraLex, The Rules Governing Medicinal Products in the European Union Volume 4 and any additional guidance given by the MHRA

Key Responsibilities 

• Following, promoting, and enforcing relevant SOPs, Job Aids, and Company policies and procedures.
• Proactively supporting the businesses operation by helping in other departments which may be busier than your own at a particular time.

 Quality Management

• Following, promoting, and enforcing all Quality related procedural documents.
• Ensuring the Pharmaceutical Quality Management System is managed and improved where necessary.
• Ensuring that the Validation system is managed and improved where necessary.
• Ensuring the Site Validation Master Plan is adhered too.
• Being involved in any audits performed by external customers or regulatory authorities where applicable.
• Being involved in internal and vendor audits.
• Leading and mentoring the direct reports as per the organisation chart.
• Monitoring and investigating trends in Quality metrics and reporting to the Quality Director.
• Leading a culture of continuous quality improvement by constant monitoring and review of the Pharmaceutical Quality Management System.
• Promoting and educating colleagues in GMP and GDP and ensuring that training is provided to all staff including subcontractors.
• Developing a strategy for the Quality Assurance Department, along with the Quality Director – ensuring continuing regulatory compliance, whilst supporting business development and meeting board objectives.
• Developing, maintaining, and encouraging constant improvement of business KPIs for the Quality Assurance department.
• Participating in the Quality Management Review meetings and following up on any actions.
• Ensuring regulatory changes are appropriately assessed for their impact.
• Undertaking project work, as part of a multifunctional team.
• Build authentic relationships with all QPL departments and companies throughout the Company to ensure continuous compliance.

Business Management

• Reviewing and monitoring regulatory top line operational performance and general business issues in conjunction with the other Head of Departments and Executive Directors.
• Continuously developing departmental systems to gain efficiency improvements and best use of resources.
• Proactively reviewing existing company policies and developing new ones to meet the needs of the business.
• Ensuring an effective communication cascade is established and maintained for all levels of information to be disseminated throughout the Quality Assurance team.
• Translating a new business opportunity into an active project subject to board approval
• Deputising for the Quality Director, where necessary.

People Management

• Building and managing a high-performing, collaborative team that always works in line with the Group’s values.
• Ensuring the appropriate level of resources and expertise is in place and that this is structured in the most effective way to deliver the strategy.
• Ensuring that the team has clear objectives in place and that they understand how these relate to the KPIs and the divisional and Group level strategy.
• Ensuring all team members have development plans in place and regularly reviewed.
• Providing regular feedback to direct reports. Proactively addressing underperformance.
• Ensuring effective communication of key messages to the team from across the Group.
• Identifying top talent and ensuring there is a plan in place to retain them, keeping them engaged and maximize their potential.
• Recognising and celebrating success on a team and individual level.

 Criteria 

• Experience of operating in a similar role is desirable.
• Demonstrable experience of working autonomously and making decisions.
• Knowledge of Pharmaceutical Quality Systems.
• At least 5+ years managerial experience.
• A recognized management qualification is desirable although not essential depending on experience.
• Strong, up to date knowledge of Good Manufacturing Practices.
• Confident dealing with managers and employees at all levels.
• Experience working in pharmaceutical/healthcare/life sciences industry advantageous.
• English and Mathematics GCSE grades A-C (or equivalent).
• Highly computer literate; experience operating with all Microsoft Office software.

Benefits

• Day Shift Hours
• Paid Holidays
• Death in service: 4x salary
• Pension: 4.5% matched
• Cycle to work / EV Scheme

Please note that this role will entail at least 4 weeks training based in the UK Monday – Friday, all expenses paid (flights, hotel & food). The desired applicant must be willing to dedicate themselves to this initial travelling in the “settling in period” before being based in Belfast full time