Location: Wavre (preferred)

Other location can be envisaged: US/UK/EU (close to a GSK Site…)

Job Purpose

As an enterprise level Global Business Process Owner, you will be responsible for forming the strategy and process for the quality devices process.  You will review data from systems and users to diagnose where change is needed and implement cross functional organisational change projects which improve business performance.  In this role, you will acts as Council Chair to collaborate with key interface partners to maintain, sustain and continuously improve process and associated tools and technologies.

The role has accountability for the standardization of the procedures that continue to increase quality culture and performance in alignment with the regulatory authority expectations. You will also provide governance of operational area leads (GSK Site, LOC, Warehousing, Distribution Centres etc) compliance with Good Manufacturing Practices (GMP), by trending the key performance indicator for your process.

Key Responsibilities

• Drive standardization, innovation, and compliance for end to end (E2E) process across the network

• Responsible for the process policy and GSOP, application, data and digital solutions associated with the process.

• Lead/facilitate community of practice (CoP) across the network

• Support audit findings and preparation on topic, act as an audit coach as needed

• Support CMC to achieve right first-time filing process for new combination product

• Represent GSK in external advocacy and sharing best practices.

• Drive the implementation needs: training of sites, support of gap/implementation assessment, tackling barriers to successful implementation at sites/LOCs

• Liaise with site SMEs throughout the process: impact assessment, design, review, implementation.  Responsible for ensuring the SME list is accurate.

• Knowledge of global regulations and guidance, global regulatory and pharmacopeial expectations, inspection intelligence, innovative/new technologies, industry standards and registered risks pertaining to area of expertise

• Define deployment strategy within GSK (QMS direct to LSOP or GSOP/Technical Standard) and have it endorsed at QMS Tier 1, or Quality Tier 2/3 Quality Council governance forums.

• Design the global standard operating procedure when required, in collaboration with One Quality QMS executive.

• Drive simplification of the process, design the training packs and capability across network

• Develop the key performance indicators,  global data review and trending of the KPI

• providing a mechanism for oversight of products manufactured in multiple locations/sites

• Responsible for optimizing the tracking processes and records within QWF/MERPS and Veeva QMS system as required.

Why you?

Knowledge/ Education / Experience Required

Educational Background

Minimum Level of Education:

• Minimum Bachelor Degree in scientific or engineering discipline, or able to demonstrate equivalent level of knowledge

Area of Specialisation:

• Biological, Biochemical, Pharmacy, Chemistry or other appropriate education

Preferred Level of Education:

• Master of Science or PhD in scientific or engineering discipline, or able to demonstrate equivalent level of knowledge

Area of Specialisation

• Biological, Biochemical, Pharmacy, Chemistry or other appropriate education

Job-Related Experience

• Minimum of 10 years of pharmaceutical/ vaccines manufacture, release & distribution.

• Good understanding of ICH Q10 Pharmaceutical Quality Systems

• In depth knowledge of medical regulations EU 2017/745 and 21CFR part 820

• Good understanding of how the topic/QMS process is implemented within global supply chain.

• Knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence, innovative/new technologies, industry standards and registered risks pertaining to area of expertise.

Other Job-Related Skills/Background

• it is desirable that the incumbent will have excellent written and verbal communication skills.  The role will require working across many different cultures, functions and manufacturing/ distribution operational areas, therefore a good span of knowledge would be advantageous.

When applying for this role, please download your CV + a cover letter to describe how you meet the competencies for this role.

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If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Why GSK?

Uniting science, technology and talent 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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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.

 
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