Job Description

Purpose

To lead a team of QA Executives / Document Controllers to provide QA oversight of Site Documentation and Training Systems to ensure ongoing compliance to Company QMS, regulatory requirements and cGMP expectations.

Key Responsibilities Area

Operations

Lead a team of QA Executives / Document Controllers to be the Process Owner for the site documentation and GMP training quality systems:

Documentation

Responsible for the documentation management system

Provides QA oversight to site document management systems, inclusive of both electronic and manual document systems

Leads the team to provide end-to-end support for all document management activities in site document management systems

Responsible for the site archival system

GMP Training System

Provides QA oversight to the GMP training system

Responsible for the site's cGMP induction and refresher trainings

Provide support for myLearning administration

Provide QA oversight to competency-based learning process

Ensures site documentation and training systems are aligned to the Vaccines network via gap assessments and QMS review

Periodically conducts compliance and performance reviews of the documentation and training systems

Review and approve SOPs and QMS gap assessments

Participate in investigations and CAPAs for issues related to documentation and training system

Identify and lead improvements

Management and Planning

Lead and supervise team of QA Executives / Document Controllers to perform operations described above.

Using capacity management, plan and organise team's day to day activities.

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

Interface with Internal and External Stakeholders

Create effective interfaces with internal and external stakeholders in the Global QA for documentation

Support interfaces with internal and external stakeholders for training systems

Training & Development

Plan and develop working knowledge and stakeholder management of the team of QA Executives / Document Controllers.

EHS

Comply with company requirements on EHS

Skill, Knowledge & Experience

Professional

5 - 7 years experience in the pharmaceutical industry in GMP regulated areas

Technical

In-depth understanding of cGMP regulatory and legal requirements as applied to quality assurance of pharmaceuticals manufacturing

Extensive knowledge and hands-on experiences of pharmaceutical manufacturing processes

Why GSK

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

GSK is a global biopharma company with a special purpose -to unite science, technology and talent to get ahead of disease together -so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns -as 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's 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 -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.

*Li-GSK

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - 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.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's 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 - 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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.