Site Name: Ireland - Dublin, GSK HQ
Posted Date: Nov 6 2024

Global Business Process Owner (GBPO) PQR and MAH Director, Trading Partner Quality

Location: Dublin, Ireland or GSK HQ London, UK

As an enterprise level Global Business Process Owner, you will be responsible for forming the strategy PQR for the end-to-end process of Periodic Quality Reviews (PQR) across the supply chains. 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 act as the leader 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, External Supply Quality, LOC, Trading Partner Quality etc) compliance with Good Manufacturing Practices (GMP), by trending the key performance indicator for your process.

This role will also act as the lead for the MAH team within Trading Partner Quality with the additional responsibilities as below:

• 
  To ensure MAH activities undertaken by the Trading Partner entities are performed in compliance with relevant regulations, licences and authorisations.
  
• To fulfil the duties as MAH representative at inspections supporting supply to China.
  
• Ensure that PQR are performed annually for centralized products under GSK TS (and GSK Ireland until project switch has concluded).
  
• Ensure the completion of Project Switch.
  
• To ensure that Trading Partners are inspection ready and ensure the oversight and delegation for MAH duties.
  

Key Responsibilities include, but are not limited to:

• 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 (Co P) across the network
  
• Support audit findings and preparation on topic, act as an audit coach as needed
  
• 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.
  
• 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
  
• Ensure medicinal products manufactured and released within the EU where the MAH is Glaxo Smith Kline (Ireland) Limited or Glaxo Smith Kline Trading Services Limited are managed in accordance with EMA/419517/2021.
  
• Act as MAH representative and fulfil the duties of the MAH to support China supply whereby they use other MAH’s as a reference.
  
• Ensure the department is inspection ready with respect to the local regulatory body and that the framework of oversight is active.
  
• Maintain the contracting framework for MAH ensuring it is fully aligned to any regulatory updates as published by the EMA or local health authority.
  
• PQRs
  
  • Deliver on the annual reporting and generation of PQR for centralized licences.
    
  • Maintain the PQR automation system and support other functions to generate PQR for local use.
    
• Quality Organisation
  
  • Lead, use and maintain the quality system within the Trading Partner organization for MAH. Ensure that the quality system complies with both GSK and external regulatory expectations.
    
  • Quality Review:
    
    • Accountable for the Glaxo Smith Kline Trading Services Limited MAH quality council process, ensuring that quality risks, issues and metrics are discussed at a leadership team level and that appropriate actions and escalations are taken.
      
  • Manage audit responses related to MAH using the relevant CAPA management database
    

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• 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
  
• Minimum bachelor’s degree in scientific or engineering discipline, or able to demonstrate equivalent level of knowledge
  
• Extensive experience in pharmaceutical/ vaccines with in-depth knowledge of PQRs
  
• Good understanding Pharmaceutical Quality Systems
  
• 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.
  

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Master of Science or Ph D in scientific or engineering discipline, or able to demonstrate equivalent level of knowledge
  
• This role requires a deep level of GMP knowledge and problem-solving skills
  
• Ability to deal with stakeholders across the globe: dealing with varied professional and cultural backgrounds
  
• Exceptional leadership skills
  
• Excellent oral and written communication skills
  
• Strong interpersonal and negotiation skills
  
• Problem identification and solving skills
  
• Ability to enable and drive change
  
• Able to work effectively in English
  

Closing Date for Applications: 20th November 2024 (COB)

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

#LI-Hybrid


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).

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