Commercial Quality Executive

This position is responsible to provide effective and efficient support to the LOC Quality Manager to maintain effective Quality Management System (QMS) and perform LOC Quality Operation activities in compliance with GSK Policies, QMS and local regulations.

Key Responsibilities

Quality Strategy

Lead and deliver LOC Quality Objectives and Improvement Plan, using KPI trend analysis to drive continuous improvement.

Maintain strong QMS knowledge and monitor commercial changes to identify opportunities and mitigate business risks.

Promote a quality-focused culture across the LOC to enhance performance and trust.

Build collaborative relationships with LOC Supply Chain, LOC Regulatory and Commercial functions to align on and achieve quality goals.

Support stakeholders in developing compliant systems, processes and policies within QMS principles.

Quality Management

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 Manager as directed.

This includes but is not limited to the following:-

Responsible for executing and maintaining a robust, sustainable and effective QMS (Quality Management System) in LOC that complies with GSK standards and policies, Good Distribution Practice and local regulations, aligned to the LOC applicability matrix

Responsible for delivering QMS related training

Responsible for ensuring the following (but not limited to) quality systems are in place and in use according to GSK QMS standard

QMS Implementation – Completion of assigned gap analysis, implementation to address any gaps identified, develop local procedures (where required), provide relevant training, promote QMS principles and seek continuous improvement of the process. Represent the LOC at relevant forums.

Quality Document Management – maintain an effective document management system to ensure documents are current and meet the required retention policy. Maintain all quality documentation in accordance with GSK policies and registered details.

Quality Training – Support an effective quality training system. Complete all required/assigned training by the due date/effective date.

LOC Quality Council – support coordination of LOC Quality Council meetings, participate in LOC Quality Council(s) in identifying Quality related issues and continuous improvement opportunities. Record and report all assigned key metrics as required.

Quality Risk Management – perform activities to support risk management process to ensure timely reporting, mitigation and escalation of quality risks

Change Control – perform quality impact assessment to ensure all planned changes at the LOC (e.g. product launch/discontinuation, Third Parties, ) that have potential regulatory and quality impact are appropriately managed through change control

Deviation Management and Corrective and Preventive Actions (CAPA) – Ensure deviations are identified, reported and investigated as per the required timelines. Support / lead investigations and root cause analysis in response to deviations, quality issues, audit findings and customer complaints; develop Corrective and Preventative Actions (CAPAs) and drive on time closure of CAPA implementation.

Quality Alerts - Ensure Quality Alerts that may have potential impact to the LOC operations are timely assessed and CAPA identified Quality Regulatory Intelligence (QRI) - Work with Regulatory and relevant cross function team to assess the impact on regulatory intelligence that may have quality implications and where appropriate, escalate to LOC Quality Manager for support. Ensure a systematic, standardised and effective approach for the management of Quality Regulatory Intelligence for the LOC

Inspection and Auditing – Support and front (f required) external GMP/GDP inspection and GSK internal Corporate GMP audit. Perform day-to-day work to support the local process that is in place for (MM) Management Monitoring (self-inspection) and (IBM) Independent Business Monitoring (internal audit)

Customer Complaints – perform activities related to Product Quality Complaints assessments, reporting, liaison with investigating sites and Named Safety Contact (for adverse event related product complaints) and timely closure of complaints with the customers. Support LOC initiatives to reduce unsubstantiated product complaints

Incident Management (including Recalls) - Assist the LOC Quality Manager in investigations triggered by local Incidents.

Artwork Management – Perform quality related activities defined in artwork process to ensure artwork content complies with registration.

Distribution Risk Assessments (DRA) – support the review of DRA’s from Sites and those owned by the LOC

Quality Operations

Accountable in ensuring products supplied to market have the right quality, safety, and efficacy and comply with local regulations.

Responsible to coordinate / lead the review of IQA (Internal Quality Agreement) and Quality Agreements with manufacturing sites (GSK Sites)/External Supply Quality (Contract Manufacturers) and LOC Regulatory to ensure compliance with registration

Responsible to perform daily quality operations ensuring the imported products are tested (when required), repacked (where required) and released in a timely manner.

Responsible to perform quality operations ensuring the incoming materials, not limited to components and reagents, and medical devices are compliance to the update to date requirements (if applicable).

Responsible to ensure local repacking (where required) performed by 3rd party repacking service provider complies with GSK standards and local regulations.

Responsible to ensure product storage and distribution performed by 3rd party warehousing and distribution service providers comply with GSK standards and local regulations

Ensure the required license/s is/are current

Why you?

Basic Qualifications:

Degree in Science or related discipline

At least 3 years of relevant working experience in the Pharmaceutical / Consumer Healthcare / Medical Device industries in Quality Assurance role

Strong understanding of and experience in leading quality assurance systems particularly in the areas of batch release, product incidents, artwork control and in the conduct of audits (internal and external)

Strong knowledge of regulatory requirements pertaining to GMP/GDP

Good knowledge of effective quality documentation systems