Job Description

Purpose

The purpose of the QA Manager (GMP Operations and Release) is to provide direction, guide and coach a team of QA professionals to ensure quality oversight on GMP operational activities and timely product release in compliance with cGMP and defined quality requirements.

Key Responsibilities Area

1. Quality oversight to Operations

Lead a team of QA professionals to manage the following:

Provide QA oversight to Value Stream - Manufacturing process operations.

QA oversight activities include establishing compliant and practical systems with stakeholders, providing QA consultation, reviewing and approving SOPs, GMP records and documents, and reviewing and approving change controls, deviations and CAPAs.

Provide QA Operations support in managing the complaints and recall investigations and systems including the associated SAP system and workflow as business owner.

Provide support to periodic product review.

2. Product Release

Manage release of product batches, including owning the QA product release workflow in SAP.

Supervise the Internal Quality Agreements (IQA) / Technical Terms of Supply (TTS) of Singapore Tuas site.

3. Management and Planning

Lead and supervise a team of QA professionals to perform operations as described above.

Strategise, plan and organise the team\'s resources to perform operations.

Report or escalate to the Line Manager or Head of Quality on key progress and issues.

4.Training and Development

Plan and develop working knowledge, decision making and stakeholder management of the team of QA Leads and QA Executives.

Establish success planning within the team.

5.EHS

Comply with company requirements on EHS

Promote the EHS culture on Site through exemplary behaviours.

6.GPS / Continuous improvement

Provide guidance and support for all activities related to GSK Production System (GPS) (e.g. Visual management, Gemba, DMAIC\xe2\x80\xa6) for continuous improvement.

Skills, Knowledge & Experience

University degree in relevant Science or Engineering discipline.

7 - 10 years experience in pharmaceutical industry preferred. Technical

In-depth understanding of cGMP regulatory and regulatory requirements of pharmaceutical industry

Confirmed regulatory inspection skills.

Significant experience in regulatory inspections.

Extensive knowledge and hands-on experiences of pharmaceutical manufacturing processes.

#Li-GSK

Why Us?

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 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. \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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GlaxoSmithKline