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Quality Assurance Manager - Cheshire - to £50k plus package
A leading facilities management organisation is urgently seeking an experienced QA Manager to join them on a Pharmaceutical client site in the Cheshire area. We require someone who has previous experience in a QA role relating to Facilities Services within a Pharma / GxP environment. The role is to ensure GxP compliance around the delivery of IFM services like cleaning and technical maintenance.
Purpose of the Job
The Quality Assurance Manager has Quality & Compliance (GxP) oversight for the Client account, and is part of a team of people based globally.
The role is required to ensure GxP compliance is maintained through supporting the operational teams in the delivery of IFM services (e.g. technical maintenance, GMP cleaning & supplier management)
This is a critical role which provides wide exposure to both us and Client management, provides a unique opportunity to learn the companys varied and diverse activities and has great opportunities for future career progression.
The Quality Assurance group provides support to the operational teams working on the Client account. The group conducts audits, provides input into training and quality investigations, all of which to ensure GxP regulations are satisfied.
This position is based in the Northwest UK however some travel (both domestic and international) may be required dependent on business needs.
Context and main issues
Enhance and improve compliance through effective deployment and utilization of Quality Management Systems (including tools and processes).
Strong collaboration with client stakeholders in what can be a complex environment.
Broad range of services that are close to the core business of our client which require careful prioritization.
Main assignments
Support and guide the operations teams to ensure all IFM services / activities comply with GXP regulations, company policies, and industry standards.
Oversee the implementation and maintenance of our / Client Quality Management Systems (QMS), including deviation management, CAPA (Corrective and Preventive Actions), change control, and documentation control.
Provide close support and guidance to operations teams, specifically on complex activities (i.e. Good Engineering Practices, preventative maintenance commissioning, calibration, validation, utilities, asset management).
Lead and/or conduct internal and external audits. Prepare audit reports, for internal and external audience and take ownership of the audit program.
Manage and administrate the hosting of audits, including audit responses, and ensure the implementation of corrective actions from audits, deviations or any other improvement plans.
Develop / deliver / administrate GxP training programs for staff to promote a culture of quality and compliance.
Identify areas for improvement in quality systems and processes. Lead initiatives to enhance efficiency and effectiveness.
Work closely with Client cross-functional teams including production, engineering, and Client QA to ensure applicable quality standards are met.
Maintain and assist the operation to maintain accurate and thorough documentation of all GxP activities. Ensure records are kept in accordance with GxP and Client requirements.
Provide regular reports on quality metrics, audit findings, and compliance status to senior management.
Advise clients, of any changes in legislation which may impact the business.
Accountabilities
Successful client and regulatory audits of GxP activities.
Timely reporting and investigation of quality related incidents and audit findings.
Added value to the business through implementing efficient, standardised systems and processes.
Good team player in an international environment, with an ability to be self-managed.
Continuous development on technical and business skills and knowledge
Flexible to perform ad hoc assignments (special audit requests, serious quality investigations, due diligence etc.)
Continuous development on technical and business skills and knowledge
Person Specification
Essential
Candidate should have a solid grounding and practical experience in working in the Life Sciences environment, particularly in hard FM (i.e. utilities, facilities, maintenance, calibration, technical services).
Have a solid background in auditing (conducting and hosting), particularly within the hard FM arena.
Ability to write persuasive and effective reports and communications, which clearly define findings and their causes, and recommendations made.
Analytical Skills: Must possess strong analytical skills. The ability to systematically gather information from a variety of sources, analyse information, identify implications of data, draw appropriate conclusions, generate viable alternative solutions to a question or problem, and evaluate the consequences of choosing each alternative.
Excellent communications skills (verbal and written) are required, with an ability to recognise the values within different cultures and acknowledge different ways of working.
Fluent English + other relevant major languages is an advantage
Established knowledge of Quality Assurance/ Quality Management / Quality Systems ideally within a Pharma/Life Sciences environment.
Extensive knowledge of current market conditions and regulations
Profile of the candidate we are looking for:
Clear thinker with determination and energy, good planning abilities, well-organised and seeks perfection.
Assertive by nature
Excellent communication and interpersonal skills with a wide spectrum of personalities.
Willing to lead by example and work on own initiative.
Strong attention to detail and accuracy.
Good numeracy and oral and written communication skills.
Able to work under pressure, whilst ensuring deadlines are met.
Able to manage, and respond positively to, change.
Keen to achieve self-development.
Challenge the status quo in order to achieve a culture dedicated to continuous improvement and best practice.
Focus and push both self and others to achieve targets and results.
Seek ways of perfecting things, raising standards, reducing errors, and overcoming omissions.
Smooth relationships when difficult circumstances prevail and develop a culture of trust both within and outside the team.
Be alert to changing situations, show flexibility in approach, adaptability in difficult circumstances, and continuously strive to achieve a result.
Commercial, judgemental and understanding of wider implications of their actions.
Project management experience
Competencies (Operational and Core)
Growth, Client and Customer Satisfaction/Quality of Services Provided
Rigorous management of results
Brand notoriety
Analysis & decision making
Leadership & people management
Innovation & change
Industry acumen
Planning & organisation
