Lifecycle Management Specialist (IMP)

Opportunity Review: Lifecycle Management Specialist (IMP) - Worthing, UK

This 12-month secondment as a Lifecycle Management Specialist (IMP) presents a compelling opportunity for professionals seeking to make a significant impact within a leading global biopharma company. The role, based at the Worthing, UK site, focuses on the crucial area of investigational medicinal product (IMP) lifecycle management, ensuring compliance and driving continuous improvement.

Key Advantages for Candidates:

• Meaningful Impact: You will play a pivotal role in ensuring the effective management of validation activities across the product lifecycle. This directly contributes to getting vital medicines and vaccines to patients efficiently and safely, aligning with GSK's purpose to unite science, technology, and talent to get ahead of disease.
• Career Growth: This position offers substantial opportunities for career progression. You will lead key activities, collaborate with cross-functional teams, and gain in-depth experience in regulatory affairs, quality management, and project management within a highly regulated environment. The emphasis on continuous improvement and harnessing new technologies means you'll be at the forefront of industry advancements.
• Diverse Experience: The role involves a broad range of responsibilities, from managing compliance and overseeing change control to contributing to regulatory submissions and maintaining site quality management systems (QMS). This breadth of experience is invaluable for building a robust career in the pharmaceutical sector.
• Collaborative Environment: You'll be working within a supportive and inclusive environment, collaborating with diverse teams. This fosters a strong sense of teamwork and provides ample opportunities for learning and professional development.
• Site-Specific Focus: The manufacturing focus at the Worthing site is on antibiotics, specifically advising consideration for those with penicillin allergies. This allows for specialized knowledge development within a critical therapeutic area.

Key Considerations for Candidates:

• Fixed-Term Secondment: This is a 12-month secondment position. Candidates should consider how this fits into their long-term career objectives and development plans.
• Site-Based Role: The role is site-based in Worthing, UK. Applicants should ensure this location is suitable for their personal circumstances.
• Health and Safety: A critical consideration for this role is the manufacturing of antibiotics at the Worthing site. Individuals with a penicillin allergy are advised against applying due to health and safety regulations.
• Regulatory Knowledge: A strong understanding of GMP, validation principles, and regulatory requirements for IMP manufacture is essential. Candidates with experience in quality management systems and dossier generation will find this role particularly relevant.
• Proactive and Detail-Oriented Approach: Success in this role requires a meticulous attention to detail and a proactive mindset to identify and address potential challenges in a fast-paced environment.
• Agile Working Culture: GSK emphasizes an agile working culture. Candidates who value flexibility are encouraged to discuss opportunities with the hiring team.

This Lifecycle Management Specialist role offers a unique chance to contribute to global health while advancing your career within a dynamic and innovative organization. If you are a motivated and experienced professional looking for a challenging and rewarding opportunity, this position warrants serious consideration.