Job Title: Lifecycle Management Specialist (IMP) - 12 months secondment
This is a site-based role in Worthing, UK.
Business Introduction
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.
Position Summary
Join us as a Lifecycle Management Specialist (IMP) and play a key role in ensuring the effective management of validation activities across the product lifecycle. In this role, you will collaborate with cross-functional teams to maintain compliance with regulatory standards and drive continuous improvement. We value candidates who are detail-oriented, proactive, and passionate about delivering high-quality results. This is an opportunity to make a meaningful impact while growing your career in a supportive and inclusive environment.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Manage the product lifecycle, ensuring compliance with regulatory requirements and company standards for Investigational Medicinal Product. Organise and lead validation activities for the manufacture of IMP.
- Collaborate with cross-functional teams to develop and execute validation plans, protocols, and reports. Act as Quality point of contact for project activities relating to the introduction of IMP.
- Provide regulatory input for the generation of CTA, PSF and dossier. Maintain site QMS for IMP.
- Oversee change control processes, ensuring validation/regulatory impact assessments are completed and documented.
-Support project activities for the qualification and manufacture of the IMP to meet project timelines. Ensure all key stakeholders, including QPs, remain current with the validation status of the product line extension.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Bachelor’s degree in a scientific or engineering discipline or equivalent experience.
-Experience with regulatory and qualification requirements for the manufacture of IMP, and a strong knowledge of GMP and validation principles within a regulated environment.
- Ability to manage multiple projects and meet deadlines in a fast-paced environment.
- Effective communication skills, with the ability to collaborate across teams and influence stakeholders.
- Problem-solving skills and a proactive approach to identifying and addressing challenges.
Preferred Qualification
If you have the following characteristics, it would be a plus:
- Advanced degree (MSc or PhD) in a scientific or engineering discipline.
- Experience with validation software systems such as SAP, Kneat, or Veeva.
- Strong knowledge of IMP manufacture and the QMS and Regulatory requirements for the introduction of a medicinal product from design through to commercial manufacture approval.
- Strong organizational skills and experience in project management.
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.