Compliance Specialist, Open to flexible working
The Compliance Specialist role will ensure WREF compliance with mandatory policies such as EHS&S, ABAC, Info Protect, Third Party Oversight and the Product Quality Management Systems as well as ensure WREF actively manages enterprise and operational risks.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Quality Management Systems (QMS): Assist the WREF QMS Subject Matter Expert with oversight and reporting on key areas of the QMS including but not limited to:- training compliance, risk management, continuous improvement, incident management, third party control across the WREF GxP areas and services.
- Monitors Quality Commitments for on-time completion for FM COE, provide intervention when needed to resolve any barriers to on-time completion and escalate when required, including Deviations, CAPA, Change Controls, Management Monitoring, Written Standard periodic reviews, Risk Management
- Competent deviation business lead investigator, including mentoring others; lead RCAs and development of ASMART CAPA
- CAPA and CAPA Effectiveness Check owner and mentor for WREF staff for Global CAPAs
- TPC (Third Party Contract Management): Provide direct support for the WREF wide deployment of third-party contractor management procedures for all WREF third party suppliers. Review of the WREF GSK Approved Supplier List to ensure content is being maintained in a compliant manner; perform ongoing review of the performance and effectiveness of WREF's TPC management programme and track resulting actions under the WREF Third Party Oversight enterprise risk treatment plan. Ensure GSK wide third-party management expectations are incorporated into WREF ways of working. Develop an offshore solution following programme stabilization.
- Operational Occurrence Reporting / Alert Management): Provide reports of operational disruptions across the WREF managed portfolio. Identify trends within and across regions to prevent future occurrences. Support the development and processing of Engineering, Safety, Quality Alerts and Bulletins. Ensure that WREF managed sites receive the latest quality and engineering alerts on an ongoing basis and reporting of outstanding alert requirements.
- Global Computer Validation: Assist the WREF lead with providing risk-based Quality Assurance oversight for validation and sustained compliance of WREF computer systems. Ensure WREF validated system documentation is current while maintaining the validation schedule, ensuring relevant reviews and periodically assessing adherence to written standards.
- Written Standards: Review Written Standards monthly overdue report for overdue/approaching overdue controlled documents; Contact document Owner to advise of document revision status. Escalate to Regional Compliance Manager as required.
- Facility Management Centre of Excellence (FM CoE) IBM: Assist the FM CoE Independent Business Monitoring (IBM) lead with identifying a risk-based universe of site services that will be reviewed periodically. Develop an assessment approach that provides assurance that key controls, across the GMP and EHS areas, are designed appropriately and operating effectively.
- Tier 1 Quality, Tier 2 Quality & RMCB Governance Meetings: Working with FMCOE team, drive FMCOE actions through to completion. Track Status of all FM COE compliance/quality activities and prepare monthly status update report outs for governance meetings. Ensure resource allocation management.
- Compliance/Quality Community of Practice - Set up a WREF One Team COP for Quality/Compliance . Work with FMCOE Compliance lead and Regional leads to develop an agenda, meeting objectives and desired outputs. Ensure minutes of meeting are taken and distributed.
- Communications - Develop calendar of Compliance/Quality Topics for Awareness campaign:- create content for monthly Workplace posts and/or inclusion in Quality newsletter on topics such as data Integrity, Information Security (phishing), Leavers process compliance, RCA's, Lessons learned from CAPAs/Deviations/ Top trends/findings , Top 10 Facts etc.
We are looking for professionals with these required skills to achieve our goals:
- Associates Degree
- broad experience in a Compliance role within Pharma industry, including Facilities, Lab Services, Calibration & Maintenance.
- Experience in Computerized Maintenance Management Systems
- Knowledge of key quality metrics associated with regulated environments (CAPA, Audits, risk assessments)
- Experience with process and computer systems, processes, and documentation required to support regulatory compliance in a Pharma.
- Excellent customer service, interpersonal and teamwork skills.
If you have the following characteristics, it would be a plus:
- University Degree
- Project Management Qualifications
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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