Qualified Person Lead

Job title:

Qualified Person Lead

Company:

GlaxoSmithKline

Job description

We have a new opportunity for a IMP Qualified Person to join our team on a permanent basis at Citywest Dublin. The successful person will perform the quality assurance activities and quality oversight of the GMP functions performed within Pharma R&D. As a Qualified Person, is personally accountable to conform to the legal regulatory requirements as stated in Clinical trials – Regulation (EU) No. 536/2014, article 4 of Delegated Regulation 1569/2017, Article 51 of Directive 2001/83/EC dependant on location.In this role you will also interact with GSK external partners and collaborators.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 50 % 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 atIn this role you will…

• Provide Qualified Person certification as defined in EU directive 2001/20/EC, regulation 536/2014, Article 51 of Directive 2001/83/EC and perform QP release of a range of Investigational medicinal products
• Ensure a compliant operation is in place to allow for EU certification of batches of Investigational Medicinal Products and assure products meet regulatory requirements and that they conform to regulatory submissions.
• Maintain knowledge of legislation changes and proposals applicable to QP Certification, evaluate impact and propose mitigation for their compliant management and/or introduction.
• Provide QP advice and consultancy working with GSK project teams, external collaboration partners and external sponsors to reduce regulatory risk to GSK and ensure information and other QP assurances are obtained (as required).
• Build and maintain effective internal GSK and External business relationships. Working with the senior EUQP’s, develop and incorporate effective processes and procedures in Product Quality Pharma R&D and may contribute to business processes and procedures outside Product Quality Pharma R&D including coaching, mentoring, or training.
• Participate in routine or regulatory audits and investigations, such as Quality Investigations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and to follow up on the implementation of those recommendations.

Why you?Basic QualificationsWe are looking for professionals with these required skills to achieve our goals:

• Science degree and /or QP eligible equivalent degree and extensive experience in pharmaceutical manufacturing and quality operations.
• Eligible to act as Qualified Person in the EU (Ireland)
• Experience with the QP certification of major dose forms such as Tablets, aseptic sterile manufacture and biopharm products
• Broad knowledge of quality management
• Capable of leading, and working in multi-disciplinary teams based in different geographical locations to develop value added-solutions.

Preferred Qualifications/ ExperienceIf you have the following characteristics, it would be a plus:

• Previous experience of working with external partners.
• Experience in QP certification of Investigational Medicinal products.
• Experienced in Regulatory Health Authority Inspections
• Proven track record of taking accountability of being able to make difficult (“grey area”) decisions, navigating the regulations, influencing stakeholders and escalating risks to senior management where appropriate.

Closing Date for Applications: 19th March 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 make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 2.3 billion packs of medicines and doses of vaccines in 2023.We continue to modernise, so we can launch even more new products at speed whilst continuing to deliver across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and 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.If you are interested in joining us, find out more: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.As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).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 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.Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the and scroll to the Careers Section where you will find answers to multiple questions we receiveAs you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.Important notice to Employment businesses/ AgenciesGSK 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.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at

Expected salary

Location

Dublin

Job date

Fri, 07 Mar 2025 07:44:02 GMT

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