Local Operating Company Quality Executive At GSK
Job Purpose
The Local Operating Company “LOC” Quality Executive roles exists to provide effective and efficient quality assurance systems support to the Local Operating Company “LOC “Quality Manager or Local Operating Company “LOC” Quality Area Lead, including supporting the implementation and maintenance of the Quality Management System “QMS” and as directed by the LOC Quality Manager performs the day to day work to ensure that the quality systems required by the LOC element of the Supply Chain and Marketing Company Local Operating Company “LOC” are performed in a lean and efficient way and meet the compliance standards of the QMS and the local Regulator.
The Local Operating Company “LOC” Quality Executive will act as Quality Representative within the Commercial Team supporting the delivery of quality management system for the nominated area or country. The role holder will also partner with the business to ensure that their business requirements are understood. The role will take supporting role to drive a quality culture within the Local Operating Company “LOC”s. The role will drive standardized business processes where applicable across Local Operating Company “LOC” to maximize business benefits
Key Responsibilities:
1. Maintain a high level of Quality Management System “QMS” knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity.
2. Act as the relevant Local Operating Company “LOC” quality contact for the Regional Quality organization providing communication to the regional quality organization on progress on Quality Management System “QMS” compliance status updates on quality plans and escalation of issues. Share learning’s and issues appropriately with other Local Operating Company “LOC” and regional colleagues.
3. Support the implementation and maintenance of effective Quality Assurance systems to ensure that local operations are in full compliance with GSK standards and policies, Guide for Commercial Companies, Good Manufacturing Practice “GMP”, Good Distribution Practice “GDP” and regulatory requirements by supporting the Local Operating Company “LOC” Quality Manager as directed
Ensure that all Standard Operating Procedure “SOP”s are in place, updated & training has been conducted across the GxP business processes. Ensure a monitoring system in place for tracking training compliance and process for escalation of persistent non-compliance. Processes in place for delivering routine training for updates to Standard Operating Procedure “SOPs as relevant.
Promote Quality Management System “QMS” management principles and seek continuous improvement of the processes
Review, conduct impact assessments and implement any updates to Quality Management System “QMS” policies
Manage QMS Management Review meetings according to local Standard Operating Procedure “SOPs”
Identify, Implement and Manage QA Objectives & KPIs
Establish and manage Annual Quality Plans
4. Support the Local Operating Company “LOC” Quality Manager to ensure that all internal procedures and systems in use in the Local Operating Company “LOC” are compliant to GSK Quality Management System “QMS”, Guide for Commercial Companies and local regulatory requirements, including (but not limited to):
Local Operating Company “LOC” Quality Council – support the LOC Quality Manager re organizing Council meeting with regular meetings. This support should ensure that the Local Operating Company “LOC” Quality Council format, frequency and reporting are standardized to global requirements. In addition, support should be provided to ensure Quality metrics and reporting format/ system in place.
Change Control – perform day to day work to support the local change control process with the aim of ensuring all planned major changes (including as appropriate new pack introduction, product discontinuation, major pack changes, re-packing activities) are effectively and compliantly managed. Processes in place to routinely review progress of changes and close out when completed.
Risk Management – perform activities to support the risk management process to ensure effective management, timely reporting, review and escalation of quality risks.
Corrective and Preventative Actions “CAPA” – Implement global or local process to effectively manage corrective and preventative action plans. Develop local processes to conduct root cause analysis to investigate deviations and develop Corrective and Preventative Actions “CAPA’s”. Local process in place to track and review Corrective and Preventative Actions “CAPA” plans on routine basis. Demonstrate that Local Operating Company “LOC” effectively identifies where Corrective and Preventative Actions “CAPA” plans required and that they are effectively implemented, monitored and closed out.
Auditing – perform day to day work to support the local process that is in place for Level 1 (self-inspection) and Level 2 monitoring auditing.
Work with the Local Operating Company “LOC” Quality Manager to ensure:
-The Level 1 and Level 2 auditing process includes clear accountability for sign off of audit reports and resultant Corrective and Preventative Actions “CAPA”/ Risk management.
-Level 1 and Level 2 audit universe is defined and agreed with Regional Quality and annual audit schedules in place.
There is a process in place to ensure all new and existing suppliers/ 3rd party contractors/ service providers that have a direct impact on product quality are identified and audited by either Local Operating Company “LOC” QA Team or the appropriate Central Team (e.g. distribution sites, repacking contractors, warehouses, freight management, samples supply, off-site archive sites, activation agencies
Close follow up on Logistica service provider “ LSP” to ensure that GDP is fully implemented.
Availability if requested to participate in Level 1 (self) and Level 2 audits with the agreement of the relevant Central Team
The Local Operating Company “LOC” element of the Supply Chain and the Quality elements of the Marketing Company are audit ready for any relevant Level 3 or 4 audits
Complaints – perform day to day work to support an effective complaints management process ensuring the assessment of potential issues are determine as quickly as possible and linked to the adverse event reporting process and local product incident process if/as appropriate. Report and follow up on product complaints with manufacturing sites, customers and commercial teams.
Incident management – Support the Local Operating Company “LOC” Quality Manager to ensure that an effective local product incident process is in place to escalate and manage any product quality related issues and in the training of all relevant staff in local incident management process and global Product Incident /Recall Committee “PIRC” process. Assist the Local Operating Company “LOC” Quality Manager in any investigations triggered by local incidents and in conducting Local Operating Company “LOC” Incident Committees.
Product supply – performs day to day work to support systems that have an impact on the quality of imported, products in line with the Quality Management System “QMS” and local Regulatory requirements
Artwork process oversight – perform Artwork “AW” KPIs improvement in line with the roles and responsibilities for quality as defined in the artwork procedures.
Local Repacking – perform day to day work to support repacking requests ensuring regulatory and QA compliance, timely QA batch release of repacked orders before distribution and/or re-export. Ensure as appropriate documentation of batch records and retention of samples.
5. Maintains all quality documentation such as product specifications and Standard Operating Procedures in accordance with GSK policies.
Ensures all product specifications and related documents (e.g. CoAs, TTs) are maintained compliant to current registered details.
Maintains and updates the QA Standard Operating Procedures
Why you?
Basic Qualifications:
Education and Experience:
Degree in a Science or related discipline (Chemistry, Pharmacy, Biology…).
Total 5 years’ experience within pharmaceutical industry and application of Quality System
High level of GMP/GDP knowledge
Exceptional leadership skills
Excellent oral and written communication skills
Proven influence and impact skills across business levels and functions
Strong interpersonal and negotiation skills
Problem identification and solving skills
Ability to enable and drive change
Able to work effectively in English
Self-starter, able to schedule and progress workload on own