Quality and Compliance Manager

Location: Stevenage 

Salary: Up to £67,000 per annum DOE

Working hours: 0800-1700, Monday-Friday, 40 hours per week

Contract Type: Permanent Full Time

Benefits: 25 days holiday + BH, Company Pension, Private Healthcare (after 6mths) Company Sick Pay + Flex Benefits.

About EMCOR UK:

At EMCOR UK, we revolutionise facilities management by combining our engineering heritage and innovation capability. We prioritise people in everything we do, collaborating closely with our customers to understand all their needs, from the big picture to day-to-day operations. Our purpose is to "create a better world at work". Using our unique insight platform, "One Data World," we harness data-driven intelligence to make informed decisions, adapting our services to meet our customers’ evolving requirements. This allows us to cultivate an enhanced workplace experience for their teams whilst optimising efficiency, meticulously managing every asset, and minimising their impact on the planet. All supported by our commitment to safety, compliance, and assurance. Our partnering approach empowers our customers to shape a better future. Whether guiding their path to net zero or redeveloping their facilities for enhanced efficiency, we create better places for work whilst taking away the burden of facility operations, freeing up our customers to concentrate on their business.

Role Overview:

This role is responsible for the delivery of efficient and compliant quality management within a facilities management operation. This includes driving a compliance culture that provides:

• Manage a team to ensure the highest levels of compliance across the contract.
• Clear guidance and interpretation of written standards and regulatory guidance.
• Ensure internal controls exist including audit functions and reporting to meet EMCOR UK and client requirements.
• Monitor systems, standards, process and procedures to ensure quality (GxP) standards are identified and maintained.
• Identify and manage risks inline with EMCOR UK and Client expectations.
• Develop a compliance culture.
  

• Accountable that activities are carried out in compliance with GSK quality arrangements.
•  Promote improvement in existing work practices through ownership and commitment from EMCOR UK personnel.
• Review the method for ensuring that all employees and any other persons employed under EMCOR UK’s direct control comply with the GSK specific quality arrangements.

• Manage with a pragmatic and problem-solving approach to regulatory related matters and foster an understanding that quality arrangements are an integral part of business and operational efficiency.
• Ensure on time completion of all quality related activities including CAPAs, Deviations, Management Monitoring, Global Quality Alerts, and other items as requested.
• Ensure robust tracking and reporting processes are in place to monitor and control all GxP actions and activities on the account.
• Develop long term strategies to ensure a culture of continuous improvement to prevent reoccurrence of deviations from procedures.
• Develop and support team to achieve appropriate objectives and prevent metric failures.
• Monitor, evaluate, review, and advise management on matters that relate to the account arrangements.
• Collate and trend KPI/Metric and investigate any potential trends or concerns. Ensure Compliance KPIs are met as per contract services.
• Review monthly quality report submitted to the line management
• Attend meetings as required

• Own the GxP Management Monitoring process to ensure compliance with GSK and EMCOR UK Quality policies, procedures, and instructions.
•  Provide end to end support to service delivery operational teams for all appropriate audits as requested.

• Provide oversite of all GxP CAPA completion and support to operational teams to appropriate CAPA planning to allow for on time completion or appropriate extension.
• Ensure all CAPAs assigned to EMCOR UK staff meet strict ASMART requirements to allow for timely completion.
• Monitor CAPA completion throughout the CAPA lifecycle to ensure on time completion.
  
  

• Report or escalate potential quality and compliance risks to the line manager.
• Oversee the management of EMCOR UK risks in the GSK risk management system.
• Ensure staff and management are able to recognise and report risks and manage risk using the appropriate tools provided by EMCOR UK and GSK.
  

• Ensure compliance to clients Third Pary Vendor Management Process.
• Oversee the assessment of third- party vendors, supplying services, equipment or materials to the GSK contract including any remedial actions and development of scopes of work.
• Ensure staff compliance to third party vendor management processes including those related to management of parts.
  

• Lead investigations into irregularities – GxP and non GxP.
• Assist with and review incidence investigation reports and make recommendations to prevent a reoccurrence.

• Establish a quality culture between the EMCOR UK , GSK and subcontractors through good communication and documentation.
• Work with EMCOR UK account management to standardise processes and systems where applicable.
• Run and develop communications and campaign strategies to deliver on cultural objectives.

• Ensure compliance team are appropriately trained and have the required skill sets to carry out responsibilities.
• Ensure resources are available to support and meet account and GSK deliverables/services.

• Significant, demonstrable experience in a quality or compliance role in preferably in a GxP regulated pharmaceutical quality, engineering, facilities maintenance, or manufacturing organisation.
• Line management experience.
• Strong written and oral communication skills.
• Ability to demonstrate project management and prioritisation skills with the ability to manage competing tasks in high pressure environments.
• Competent use of Microsoft Office.
• Investigative skills: including knowledge and experience using different tolls for running root cause analysis
• Able to demonstrate a proactive attitude to dealing with actions, risks, and concerns or questions raised by others.
• Highly computer literate having used an array of different computer systems which may include: procurement tools, data bases, computerised maintenance management systems, learning management systems, electronic document management systems, etc.
• Excellent interpersonal and communication skills to effectively work with management and employees at all levels within an organisation, including key stakeholders, customers and facing regulatory auditors.
• Must have demonstrable experience providing leadership creating a safe, team-based, high-performance, quality-driver environment.

• Degree in Engineering/manufacturing within pharmaceutical/healthcare industry, or equivalent related work experience within a regulated manufacturing environment.
• Extensive experience and knowledge of GxP guidelines and regulations (GMP, Medical Devices, Clinical, ISO).
• Specialised training or certification in quality assurance audits.