MAH / PQR Process Manager (contract / secondment)

This role 12 months contract / secondment.

As MAH / PQR Process Manager you will work with the GBPO to develop a strategy for the end-to-end process for PQR across Medicines, Vaccines, CMO and central functions. You will lead deployment activities for the New Global PQR solutions in the supply chain. You will act as a subject matter expert for MAH activities and ensure compliance and oversight of MAH activities for Trading Partner entities comply with relevant regulations, licences and authorities.

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

In this role you will

MAH & PQR Compliance

• Ensure compliance and oversight of MAH activities for Trading Partner entities comply with relevant regulations, licences and authorities.
• Monitor and interpret new compliance requirements, regulations, and guidelines relevant to MAH/PQR in the pharmaceutical industry.
• Assess the impact of new compliance requirements on existing PQR/MAH processes and systems.
• Ensure the MAH/PQR process complies with all relevant regulatory requirements and industry standards.

MAH Oversight & delegation

• 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 & EU. Ensure that PQR are performed annually for centralized products under GSK TS.
• To ensure that Trading Partners are inspection ready and ensure the oversight and delegation for MAH duties.
• Maintain the contracting framework for MAH ensuring it is fully aligned to any regulatory updates as published by the EMA or local health authority.
• Lead, use and maintain the quality management system within the Trading Partner organization for MAH. Ensure that the quality system complies with both GSK and external regulatory expectations.

PQR Build & Deploy

• Be accountable for developing, communicating and deploying the global PQR process and standard template for process, data and technical strategy with PQR users and key stakeholders.
• Ensure system design meets defined business requirements
• Work with the sites/LOCs/central teams/EM to create a business change management /readiness plan for deployment which is in line with the new global PQR template
• Produce a plan and schedule of work activities in accordance with the demand schedule timelines
• Ensure that the plan is adhered to and delivery of actions are completed to the correct standard
• Identify issues and risks arising from the proposed deployment or which put deployment at risk
• Support the PQR users in reviewing change readiness plans and making go / no go decisions
• Enable change in line with the PQR processes and collaborative learning between the sites, CMOs and markets as implementation progresses
• Conduct training sessions for relevant stakeholders to ensure understanding and effective execution of the PQR process.
• Management of demand between Medicine/Vaccine sites, LOCs, central teams and CMO.

Embed & Grow standards, drives continuous improvement

• Co-ordinate template changes
• Facilitate the Process for Communities of Practice
• Act as a PQR SME and support PQR users in the Supply Chain.

Why you?

Basic Qualifications & Skills:

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

• Bachelor's degree in a relevant field (e.g., Pharmacy, Life Sciences, Quality Management)
• Extensive relevant experience of pharmaceutical quality assurance / regulatory and distribution / manufacturing. Experience in a business process role in a complex global organisation.
• Deep level of GxP, MAH and Regulatory Framework knowledge and problem-solving skills
• Excellent oral and written communication skills. Able to work effectively in English
•  Understanding of data management and/or quality assurance processes.
• An understanding of the systems development cycle, supporting documentation, change control and validation processes.

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Ability to deal with stakeholders across the globe: dealing with varied professional and cultural backgrounds
• Proven influence and impact skills across business levels and functions
• Strong interpersonal and negotiation skills
• Problem identification and solving skills
• Ability to enable and drive change

Closing Date for Applications – 22 July 2025 (COB)

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.

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance.

Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.

We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

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.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391.  The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.

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