Job Description

Purpose

The Operational Quality Manager is responsible for ensuring Quality Assurance oversight of operational activities onsite which includes all processes for raw materials, intermediates, and final products. This role leads and manages the OQ team to ensure that the site operates in a compliant, effective, and sustained state of cGMP control to support the manufacturing and supply processes. This includes Inspection Readiness, Deviation and Incident Management, Compliance with Internal and External Policies, and Batch Disposition.

Key Responsibilities

Manage and ensure that all policies and procedures relevant to operational quality are in full compliance with cGMP and Group requirements (includes manufacturing processes and facilities, plant cleaning, new product introduction, laboratory processes and computer systems).

Lead a team of Quality Officers to provide guidance on operational quality matters to the business.

Ensure oversight of facilities, equipment and personnel to ensure compliance to procedures, instructions, data integrity and other cGMP requirements.

Ensure that all attributes / elements contributing to product release decisions has been fulfilled promptly in accordance with cGMP and regulatory requirements.

Participate in failure investigations, and evaluate the impact of corrective actions to ensure maintenance of the validation status.

Lead or participate in investigations arising from customer/vendor complaints, returned goods or product failure etc., and accurately assess the impact of the complaints / failure so as to make appropriate recommendations on remedial actions for follow-up.

Review, evaluate and approve changes that have / could have an impact on the quality, validation and regulatory status of the manufacturing facility, processes or systems. These include changes to product specification, method of analysis, process, plant and raw material supply.

Lead and participate in internal corporate and external regulatory audits to ensure compliance with site, corporate quality management system, industrial or regulatory requirements.

Review and approve quality system related procedures.

Ensure that Material Qualification are reviewed and impact on product quality, validation, and regulatory have been assessed and that the new supplied materials are introduced and implemented in a controlled manner.

Ensure that all aspects of supplier management, e.g. supplier change control, reduced testing documentation, Product Requirements Specifications, Outsourced supplier quality management, have appropriate assessments in place for impact on product quality, validation, and regulatory

Ensure adequate and competent resources are available to support Operational quality activities.

Manage, develop, and motivate staff to help realise their maximum potential so as to contribute towards achieving the objectives of the department.

Develop and manage the budget for the section to ensure achievement of operational targets.

Skills, Knowledge, Experience

At least a degree preferably with honours in the relevant science discipline

At least 10 years of relevant experience from the pharmaceutical industry

Very good knowledge of GMP, compliance and validation

Very good knowledge of group quality management system requirements and regulatory standards

Good knowledge of overall manufacturing activities

Knowledge of fiscal impact of quality / validation / regulatory decisions/business processes

People management skills and Good communication skills

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Why GSK

Uniting science, talent, and technology to get ahead of disease together

GSK is a global biopharma company with a special purpose \xe2\x80\x93to unite science, technology and talent to get ahead of disease together \xe2\x80\x93so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves \xe2\x80\x93feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

#Li-GSK

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. \xe2\x80\x8b

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves \xe2\x80\x93 feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.\xe2\x80\x8b

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