GSK
Pharmaceutical
CommercialQualityExecutive(1yearfixedterm)
“Commercial Quality Executive (1 year fixed term) at GSK. Skills: Quality Management System, Quality Assurance, GMP/GDP. Lead and deliver LOC Quality Objectives and Improvement Plan. Maintain QMS knowledge and monitor commercial changes”
What You'll Achieve.
Lead and deliver LOC Quality Objectives and Improvement Plan; drive continuous improvement; enhance performance and trust; align on and achieve quality goals; ensure that local operations are in full compliance; continuous improvement of the process; drive on time closure of CAPA implementation; timely assessed and CAPA identified; timely closure of complaints with the customers; Support LOC initiatives to reduce unsubstantiated product complaints; ensure products supplied to market have the right quality, safety, and efficacy; ensure compliance with registration; ensure imported products are tested (when required), repacked (where required) and released in a timely manner; ensure the incoming materials, not limited to components and reagents, and medical devices are compliance to the update to date requirements; ensure local repacking (where required) performed by 3rd party repacking service provider complies with GSK standards and local regulations; ensure product storage and distribution performed by 3rd party warehousing and distribution service providers comply with GSK standards and local regulations
Industry & Context.
problem-solving skill within a structured process
What They're Looking For.
Must Have
At least 3 years of relevant working experience in the Pharmaceutical / Consumer Healthcare / Medical Device industries in Quality Assurance role, 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), knowledge of regulatory requirements pertaining to GMP/GDP, Good knowledge of effective quality documentation systems
Nice to Have
Background/experience as a Pharmacist., Broad-based knowledge and application of cGMP quality principles, Professional communication – both verbal and written, Analytical mind, good attention to detail and problem-solving skill within a structured process, Ability to engage and work well in cross-functional teams
What You'll Do.
Lead and deliver LOC Quality Objectives and Improvement Plan
Maintain QMS knowledge and monitor commercial changes
Promote a quality-focused culture
Support stakeholders in developing compliant systems
Support the implementation and maintenance of effective Quality Assurance systems
Responsible for executing and maintaining a robust QMS
Responsible for delivering QMS related training
Responsible for ensuring quality systems are in place
Represent the LOC at relevant forums
Maintain an effective document management system
Support an effective quality training system
Support coordination of LOC Quality Council meetings
Perform activities to support risk management process
Perform quality impact assessment
Ensure deviations are identified
reported and investigated
Ensure Quality Alerts are assessed
Work with Regulatory and relevant cross function team
Support and front external GMP/GDP inspection
Perform day-to-day work to support local process
Perform activities related to Product Quality Complaints assessments
Assist the LOC Quality Manager in investigations
Perform quality related activities defined in artwork process
Support the review of DRA’s
Accountable in ensuring products supplied to market have the right quality
Responsible to coordinate / lead the review of IQA
Responsible to perform daily quality operations
Responsible to perform quality operations ensuring incoming materials
Responsible to ensure local repacking performed by 3rd party
Responsible to ensure product storage and distribution performed by 3rd party
Ensure the required license/s is/are current
How You'll Work.
Team & Collaboration
Build collaborative relationships with LOC Supply Chain, LOC Regulatory and Commercial functions; Support stakeholders in developing compliant systems; Work with Regulatory and relevant cross function team; Ability to engage and work well in cross-functional teams
Communication Scope
Professional communication – both verbal and written
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