The purpose of this role is to provide direct oversight and reporting of key safety, quality and compliance data to demonstrate control of WREF’s services and sites. The information managed will provide information on not only historical performance, but also use to predict future performance. The incumbent will support WREF’s sites (Ware R&D, Harlow, Clinical Unit Cambridge, and Stevenage) and service owners. This data will be used to aid critical decisions about site and service performance.
This role will also be responsible for coordinating audit support both internal and external in order to support the site team and ensure responses are met in a timely manner.
• Experience in a highly regulated industry, competence in current Good Manufacturing Practice (cGMP) would be desirable.
- Audits, Deviations, CAPA Management (GxP): Support site based WREF and Service Partner teams through preparations and during internal and external regulatory inspections. Provide consultation and oversight to audit responses as well as Deviations and CAPA.
- CARISMA: Assist staff to obtain access to CARISMA; Enter records into CARISMA on behalf of WREF staff, i.e. Root Cause Analysis, CAPAs; Manage log of WREF Deviations/CAPAs/Findings with lead and lag metrics; Prepare WREF Overdue CAPAs/Deviations slides for WREF Tier 1 Quality Council; Maintain tracker of WREF Investigations.
- Audits and CAPA Management (EHS): Support site based WREF and Service Partner teams through preparations and during internal and external EHS inspections. Provide consultation and oversight to audit responses as well as Root Cause Analysis and CAPA support.
- Change Control: Monitor Change Control (MaCC) Reports for WREF overdue/approaching overdue change controls. Contact Change Owner to advise of change control status. Escalate to Manager as required; Assist WREF Change Owners to promote change control through lifecycle in IMMS; Archive WREF Change Controls to PIER.
- Audits and Assessments: Maintain WREF Audit Universe tracker including: Record all audits globally which affect WREF such as Quality (IBM, A&A, Regulatory), EHS &WREF IBMs; identify points of contacts for respective audits; distribute audit reports to appropriate audience and ensure Finding Owners are identified.
- Document Management: Review Optimum monthly overdue report for overdue/approaching overdue controlled documents; Contact document author to advise of document status. Ensure SOPs are followed and escalate to Manager areas of concern/non-conformance as required.
- Management Monitoring (Non GxP/EHS): Distribute WREF Management Monitoring schedule and ensure adherence to schedule; Responsible for collecting output from Management Monitoring assessments and storing respective records in a designated repository; Maintain Master 3rd Party Lists on behalf of WREF site teams. Conduct MM activities when directed by Manager.
- Management Monitoring (GxP) – When required, perform WREF GxP Management Monitoring as per schedule in conjunction with the US Compliance Coordinator to ensure consistency across the sites is maintained. Assign actions for any deficiencies identified, ensure action owners are aware and the due dates are met. Escalate any findings to the UK/UK Compliance Managers for awareness. Report schedule adherence and any overdue actions at the Tier 1 Quality Council.
- Risk Management: Grant access to RMS; Assist staff to enter records into RMS; Prepare metric reports from RMS and notify staff of overdue/approaching overdue risk activities.
- Quality Councils: Delegate for Manager at site/business group Quality Councils as requested. Prepare Performance Metrics and Risk slides and present to the Tier 1 Quality Council. Present the detail at the Tier 1 Quality Council when required. Ensure minutes are documented, distributed and archived into PIER in line with GSK Global Retention Policy.
- System Support: Assist new starters and existing team members with the use of Risk Management System, Controlled Document Management System, General Content Management System, International Modules Management System, Carisma, MyLearning, Qlikview, Spotfire reporting tools and EHS Central when required.
- Compliance Metrics: Collate all compliance metrics on a routine basis relating to the above activities into one report for the site comm cells, to ensure Management have clear visibility of the actions assigned to the sites and can drive performance. Supply compliance data for the Leadership Team meetings on a routine basis.
- Site Comm Cells: Actively participate in site comm cells, display trending data, compliance reports, near miss reporting and audit schedules to ensure site teams are fully aware of the compliance activities relevant to site and teams. Offer advise on areas of compliance as required. Escalate any concerns to Manager/Comm Cell teams when identified.
About You:This role would suit a driven and motivated individual who has strong experience of working in a complex operational environment. Strong people-management skills and experience, as well as a proven ability to drive performance, are considered essential. It is imperative in this role that you demonstrate an ability to drive common-objective thinking, with a complete focus on providing solutions. You will need to be persuasive, have a strong continuous improvement mindset, and have proven experience of dealing with diverse internal and external stakeholder groups. Ideally you will have worked in a highly regulated-industry (experience of the provision of complex facilities support services to a large office or pharmaceutical facility would be highly advantageous).
About GSK:GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing over 100,000 people globally, we have 71 manufacturing sites around the world. For more information on GSK please refer to our website: www.gsk.com
GSK’s Worldwide Real Estate and Facilities (WREF) deliver the right space in the right location, and at the right cost, with industry competitive and customer focused services. The organisation oversees and operates circa 16 million square feet of space with a population of over 28,000 GSK and other staff, including all pharmaceutical and consumer health R&D laboratories and pilot plants, as well as commercial office accommodation for all GSK business units. This portfolio of property currently requires an annual spend of more than £450m in operating costs and £200m in capital investment.