Senior Quality Executive

Key Responsibilities

Quality Strategy

• Responsible to execute and deliver LOC Quality Objectives through implementation and maintenance of an effective Quality Management System (QMS) by ensuring compliance with Haleon standards and policies, GMP, GDP and relevant local regulatory requirements.

Quality Management

• Responsible for executing and maintaining a robust, sustainable and effective QMS (Quality Management System) in LOC that complies with Haleon standards and policies, Good Distribution Practice and local regulations
• Responsible for quality performance of the assigned 3rd party contractors/ service providers/ suppliers to ensure potential Quality and compliance issues are identified, communicated and promptly resolved
• Responsible for ensuring the following (but not limited to) quality systems are in place and in use according to Haleon QMS standard
• LOC Quality Council – coordinate LOC Quality Council meetings, participate in LOC Quality Council(s) in identifying Quality related issues and continuous improvement opportunities
• Quality Risk Management – perform activities to support risk management process to ensure timely mitigation of quality risks
• Change Control – perform quality impact assessment to ensure all planned changes at the LOC (e.g. product launch, distributor) that have potential regulatory and quality impact are appropriately managed through change control
• Auditing – Perform self-inspections at the LOC and 3rd party service providers’ operations with potential product quality and regulatory compliance impact
• 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
• Incident Management – Assist the LOC Quality Manager in investigations triggered by local incidents
• Corrective and Preventive Actions (CAPA) – Support investigations and root cause analysis in response to deviations, quality issues, audit findings and customer complaints; develop Corrective and Preventative Actions (CAPAs) and on time closure of CAPA implementation
• Artwork Management – Perform quality related activities defined in artwork management process to ensure artwork content complies with registration.
• Quality system review trending – Assist the LOC Quality Manager in quality system review to drive continuous improvement within the area or country level.

Quality Operations

• Accountable in ensuring product supplied to market have the right quality, safety, efficacy and comply with local regulations.
• Responsible to coordinate the review of TTS (Technical Terms of Supply) and Quality Agreements with manufacturing sites (Haleon Sites)/CMO (Contract Manufacturers) and LOC Regulatory to ensure compliance with registration
• Responsible to ensure local repacking performed by 3rd party repacking service provider complies with Haleon standards and local regulations.
• Responsible to ensure product storage and distribution performed by 3rd party warehousing and distribution service providers complies with Haleon standards and local regulations

Requirements

Education and Experience:

• First Degree in scientific or engineering discipline, or able to demonstrate equivalent level of knowledge
• Scientific and Engineering background
• At least 5 years of relevant working experience in the Pharmaceutical / Consumer Healthcare / Medical Device industries in Quality Assurance role

Essential Skills and Abilities:

• Strong interpersonal and communication skills
• Problem identification and solving skills
• Ability to enable and drive change
• Able to work effectively in English
• Ability to work under pressure and multi-tasked