Job PurposeThe purpose of this job role is to assure that material and service suppliers within the scope of SQ A&C meet applicable GSK and Regulatory requirements.
This is delivered by:
- Execution of documented assessments of the compliance status of assigned suppliers.
- Management of supplier CAPA plans to close identified gaps resulting from said documented assessments.
- Maintenance of audit and user site data for assigned suppliers in GSK supplier management system.
- Interfacing with the supply base while providing an “inward facing” contact with designated GSK site(s) to ensure effective management of supplier issues.
Key Responsibilities
Supplier assessment, approval & compliance
- Responsible for performing Quality System assessments/audits of assigned suppliers within role scope; making a risk-based recommendation on the GMP approval status of the supplier (including proposals about the continued use of suppliers with marginal compliance, as applicable) and documenting the assessments/audits in the relevant systems within the targeted timelines.
- Responsible for agreement of appropriate corrective and preventive action (CAPA) plans with suppliers and follow-up on the completion of agreed CAPAs within agreed timelines.
- Responsible for ensuring that all audit related documentation is communicated out within the targeted timelines and that CAPA related documents are reviewed and responded to within targeted timelines.
- Responsible for performing agreed For Cause/Target audits to support supplier complaint investigations / supplier changes for significant quality incidents at supplier sites.
- Responsible for maintenance of “auditee” (supplier) profiles in the relevant data systems and ensuring that all data associated with the supplier assessment and user sites are kept current based on currently available information provided.
- Responsible for completing actions associated with supplier change controls / change notifications and supporting the Quality Assurance Agreements (QAAs) for assigned suppliers, as appropriate.
- Responsible for leading and/or supporting the management of third party audits performed by auditing firms and/or contract auditors performing audits on behalf of GSK as required to ensure process compliance and the quality of the supplier audit, as assigned.
Risk Management
- Responsible for collating identified risks and escalating high risk issues/situations to ensure management and stakeholders understand the technical, regulatory and quality risks and that appropriate mitigating actions are identified.
Regulatory / Customer inspection support
- Responsible for providing relevant support to GSK sites undergoing regulatory/customer inspections, as assigned.
Supplier assessment, approval & compliance
- Responsible for performing Quality System assessments/audits of assigned suppliers within role scope; making a risk-based recommendation on the GMP approval status of the supplier (including proposals about the continued use of suppliers with marginal compliance, as applicable) and documenting the assessments/audits in the relevant systems within the targeted timelines.
- Responsible for agreement of appropriate corrective and preventive action (CAPA) plans with suppliers and follow-up on the completion of agreed CAPAs within agreed timelines.
- Responsible for ensuring that all audit related documentation is communicated out within the targeted timelines and that CAPA related documents are reviewed and responded to within targeted timelines.
- Responsible for performing agreed For Cause/Target audits to support supplier complaint investigations / supplier changes for significant quality incidents at supplier sites.
- Responsible for maintenance of “auditee” (supplier) profiles in the relevant data systems and ensuring that all data associated with the supplier assessment and user sites are kept current based on currently available information provided.
- Responsible for completing actions associated with supplier change controls / change notifications and supporting the Quality Assurance Agreements (QAAs) for assigned suppliers, as appropriate.
- Responsible for leading and/or supporting the management of third party audits performed by auditing firms and/or contract auditors performing audits on behalf of GSK as required to ensure process compliance and the quality of the supplier audit, as assigned.
Risk Management
- Responsible for collating identified risks and escalating high risk issues/situations to ensure management and stakeholders understand the technical, regulatory and quality risks and that appropriate mitigating actions are identified.
Regulatory / Customer inspection support
- Responsible for providing relevant support to GSK sites undergoing regulatory/customer inspections, as assigned.
Internal Supplier Quality processes
- Responsible for participating, as applicable, in the development of internal Supplier Quality processes to ensure compliance with the GSK QMS (Quality Management System).
- Responsible for completion of all relevant training curriculums within the stipulated time frame.
- Responsible for following the relevant SQ A&C and QAC procedures.
- Remain current with technical processes (supplier and GSK), industry trends and changes in the regulatory and external environment, as needed.
- Perform Management Monitoring of SQAC / QAC processes including leading the development and implementation of CAPA to mitigate identified risks.
Interfaces
- Routinely interfaces with site Quality/Procurement, Procurement Commodity teams, SQ Ops/QSIM and GSK suppliers – Providing a two way communication regarding supplier audit results and impact on materials, components and services delivered to the site, supplier audit results, CAPA plans, STPs, NDA/CDA, etc.
Educational Background
Minimum Level of Education - A Science degree and adequate relevant experience (3 years) Pharmaceutical /BioPharma / Vaccines manufacturing, quality operations and/or supplier quality management
Area of Specialisation - Relevant Science (Biology, Chemistry, Pharmacy) or Food / Chemical/ Biotechnology or equivalent Engineering Degree
Why is this Level of Education Required? -
To enable reasonable understanding of the various regulations, standards and production processes of various materials sourced by GSK and how those materials are used by GSK in order to make appropriate risk-based decisions regarding supplier approval recommendations. To be a more effective auditor
Preferred Level of Education - Graduate degree in relevant Science (Biology, Chemistry, Pharmacy) or Food / Chemical / Biotechnology or equivalent Engineering area of expertise
Minimum Level of Job-Related Experience required
- Proficiency and experience in planning and executing audits to identify and reduce significant risks / non-compliances.
- Knowledge of regional/global GMP and GSK quality requirements and ability to explain these and relate them to GSK manufacturing operations and supplier operations, applying good business judgment in doing so.
- Awareness of business environment and ability to build networks and relationships with third party suppliers and internal stakeholders.
- Proficient influencing and negotiating skills to ensure supplier access for assessment, implementation of appropriate corrective actions, etc.
- Good verbal and written communications skills to ensure effective relay of issues, risks and opportunities so that these are well understood by all parties and that effective action plans can be put in place to address identified issues/risks.
- Proficiency in verbal and written English.
- Experience with Microsoft Office applications and ability to learn and apply new software applications as required as part of role (e.g., audits management software, remote virtual meetings management, etc.)
Other Job-Related Skills/Background
- Ability/Availability to travel (locally, domestically and internationally, as needed) to suppliers within region to conduct appropriate assessments.
- Good time-management skills to ensure assigned activities and associated documentation are completed within the required timelines.
- Demonstrated ability to function effectively in a matrix organization across multiple cultural and geographical boundaries.
- Nationally recognized auditor certification OR GSK Certified Auditor status preferred.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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