Qualified Person

7 days ago


Harlow, United Kingdom GSK Full time

We have a new opportunity for a Qualified Person (or trainee QP close to eligibility) to join our team on a permanent basis at Harlow. The successful person will perform the quality assurance activities and quality oversight of the GMP functions performed within Pharma R&D. You’ll provide expert oversight, certification, and release of products, ensuring they meet regulatory standards and support GSK’s mission to get ahead of disease together. Collaborating with cross-functional teams and external partners, you’ll contribute to innovation, continuous improvement, and patient safety. This is an opportunity to grow your career, make a meaningful impact, and be part of a team that values inclusion, integrity, and excellence. In this role you will … Provide QP certification and release investigational medicinal products in compliance with EU and UK regulations. Ensure compliant operations to meet regulatory standards, guaranteeing product quality and conformity to submissions. Stay ahead of legislative changes, assess their impact, and implement mitigation strategies. Offer expert QP advice to internal teams, external collaborators, and sponsors, reducing regulatory risks and ensuring critical assurances. Build strong relationships across GSK and with external partners, contributing to process improvements and mentoring others within the organization. Participate in audits, investigations, and quality reviews, recommending and implementing corrective actions where necessary. Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: Science degree and extensive experience in pharmaceutical manufacturing and quality operations. Eligible to act as Qualified Person in the UK (or imminently ready to submit for Viva) Extensive experience working alongside QP’s certifying major dose forms such as Tablets, aseptic sterile manufacture and biopharm products Broad knowledge of quality management Capable of working in multi-disciplinary teams Preferred Qualifications/ Experience If 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 of Regulatory Inspections Certification of Investigational Medicinal Products Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. 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 UKRecruitment.Adjustments@gsk.com 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 link and scroll to the Careers Section where you will find answers to multiple questions we receive. 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. 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 https://openpaymentsdata.cms.gov/ #J-18808-Ljbffr


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