Job Purpose:

The job exists within the commercial Rx Local Operating Companies to ensure that the mandated GSK Quality Management Systems requirements for commercial operating units are met. The function is critical to the effective management of systems and activities that are crucial or have a direct impact to product quality and regulatory compliance. The job holder is expected to show committed execution in implementing and sustaining the QMS including encouraging the Commercial Rx business to own quality activities in their day-to-day work.

Key Responsibilities:

Quality Management System:

• Supporting the LOC Quality Head to ensure a robust, sustainable and effective QMS (Quality Management System) through monitoring and reviewing the compliance status within the LOC element of the Supply Chain and the LOC.
• Support the implementation and maintenance of effective Quality Assurance systems to ensure that local operations are in full compliance with GSK standards and policies, GMP, GDP and regulatory requirements by supporting the LOC Quality Head as directed to:
• Gain an understanding of the Supply Chain and Commercial LOC Business and Quality Plans at a high level as they potentially link to day to day and quality improvement activities.
• Implement, execute and maintain effective Quality Assurance systems to ensure that local operations are in full compliance with GSK standards and policies, Guide for Commercial Companies, GMP, GDP and regulatory requirements by performing the following:
• Ensure that all SOPs are in place, updated & training has been conducted across the business. 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 SOPs, GQPs, GQMPs as relevant.
• Promote QMS management principles and seek continuous improvement of the processes, conduct impact assessments and implement any updates to QMS policies.
• Identify, Implement and Manage QA Objectives & KPIs, establish and manage Annual Quality Plans
• Share learning’s and issues appropriately with other LOC and regional colleagues.

Quality Governance:

Support the LOC Quality Manager to ensure that all internal procedures and systems in use in the LOC are compliant to GSK QMS and local regulatory requirements, including (but not limited to).

• LOC Quality Council –organizing Council meetings with regular periods including all relevant business functions. Ensures that the LOC Quality Council format, frequency and reporting are standardised to global requirements.
• Change Control – Ensuring effective local change control process in place to manage all planned changes within the system. Processes in place to routinely review progress of changes and close out when completed.
• Risk Management - Local risk management process in place across business with common review and escalation process. Local process in place to manage, report, review and escalate quality risks. Able to present risks at the local risk management board.
• Corrective and Preventative Actions (CAPA) - perform activities as appropriate to effectively manage corrective and preventative actions. Ensure to conduct root cause analysis to investigate deviations and develop CAPA’s. Process in place to track and review CAPA plans on routine basis. Demonstrate that LOC effectively identifies where CAPA plans required and that they are effectively implemented, monitored and closed out. Ensure CAPA are tracked periodically as per the performance review.
• Incident management – Ensure effective local product incident process in place to escalate and manage any product quality related issues. Must be well documented process and link into Quality Council as well as into PIRC process. All relevant staff trained in local incident management process and global PIRC process. Process in place to track and review temperature excursions and distribution incidents are logged into system and investigated.
• Auditing – Ensure effective process in place for MM and IBM auditing – including accountability for sign off of audit reports and resultant CAPA. MM and IBM audit universe defined and agreed with LOC Quality Head and annual audit schedules in place. Processes 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 LOC QA team (as applicable) according to agreed audit schedule. Ensure LOC is audit ready for any relevant Level 3 or 4 audit.
• Complaints – Ensure effective complaints management process in place also considering the trends and identify improvement opportunities with link to HSI reporting and be able to determine product quality issues and link into local product incident process. Ensure report and follow up on product complaints with manufacturing sites, customers and commercial teams have been performed by the Quality executive.
• Batch Release and local repacking- Managing repacking requests ensuring all stakeholder approvals acting as the primary liaison with the supplying sites and regional quality as it relates to approval of repacking activities and resolving quality issues with the product supplied, liaison with external supply quality for products that are manufactured by contractors to ensure compliance to local technical details, support on the timely local quality release of finished products and appropriate documentation of batch records. Responsible for the review and approval of IQA (Internal Quality Agreement) and liaison with manufacturing sites to ensure compliance to local registered technical details. Oversight on returned goods and ensure quality decision is made for each returned good. Acts as the responsible manager deputy in cases where the responsible manager is not available.

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Minimum of 3-5 years' experience within the Pharmaceutical / Consumer Healthcare industries.
• Successful completion of relevant science degree.
• Strong understanding of and experience in quality assurance systems particularly in the areas of batch release, product incident management, governance processes and performing audits.
• Strong knowledge of regulatory requirements pertaining to GMP/GDP.
• Good team player – works well in cross-functional teams.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Professional written and verbal communication skills.
• Ability to deliver clear communications and foster good working relationships with peers and management.
• Ability to influence and motivate stakeholders at any level of the LOC organization.
• Analytical mind, good attention to detail and problem solving skills within a structured process.
• Concise and persuasive in the description of the different QA situations. Able to stick to the standard and not be pressurized.
• Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods.
• Flexible thinking – able to challenge and see views from different perspectives.
• Ability to self-motivate and be resilient and focused under pressure.
• Able to effectively enable and drive change across cross functional stakeholders.
• Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook.

Job Posting End Date: February 25, 2024

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

Contact information:

You may apply for this position online by selecting the Apply now button.

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