Lifecycle Management Specialist (IMP)

GSK; Worthing; On-site; GBP 40,000 - 60,000; Full time

Job summary

A global biopharma company is seeking a Lifecycle Management Specialist to manage the product lifecycle ensuring compliance with regulatory standards. The role involves cross-functional collaboration and continuous improvement initiatives. Candidates should hold a Bachelor's degree in a scientific or engineering discipline, with experience in the manufacture of Investigational Medicinal Products. This site-based position in Worthing demands attention to detail and a proactive approach to problem-solving.

Qualifications

• Experience with regulatory and qualification requirements for the manufacture of IMP.
• Strong knowledge of GMP and validation principles within a regulated environment.
• Ability to manage multiple projects and meet deadlines.

Responsibilities

• Manage the product lifecycle ensuring compliance with regulatory requirements.
• Collaborate with teams to develop and execute validation plans.
• Provide regulatory input for the generation of documents and maintain site QMS.

Skills

Regulatory compliance

Project management

Effective communication

Problem-solving

Education

Bachelor's degree in a scientific or engineering discipline

Tools

SAP

Kneat

Veeva

Job description

Overview

Job Title: Lifecycle Management Specialist (IMP) - 12 months secondment

Closing Date for Applications – 2nd December (COB)

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 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 to help us on our journey to make more complex products, harnessing 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

• 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 Qualifications

• 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 Qualifications

• 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.

Manufacturing at the Worthing site is for antibiotics. Consider this when deciding to apply. We cannot accept applications from individuals with an allergy to penicillin due to Health and Safety.

We encourage you to apply if you are excited about this opportunity and meet the qualifications. Join us in making a difference and advancing your career in a dynamic and inclusive environment.

Why GSK?

GSK is a global biopharma company focused on uniting science, technology and talent to get ahead of disease together. We are committed to creating an environment where our people can thrive and focus on what matters most while delivering for patients, shareholders and our people. GSK is an Equal Opportunity Employer with protections described in our policy.

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