Introduction to role
Join us as a Product Quality Lead in our Product Quality team! The Product Quality Lead (PQL) role is a key source of Quality advice to the Product Development and Quality organizations. Be part of a distributed team of Product Quality professionals embedding Quality from Development to commercialization. The role involves interpreting external regulatory requirements and expectations into appropriate quality standards and ensuring their application by providing direction to the relevant organizations. The PQL represents Development Quality on the CMC project teams as the “Voice of Quality” ensuring intrinsic quality is built into our portfolio of products and is the primary point of contact for technical product quality advice from Development Quality. Development Quality is a Global group, with teams located in Gothenburg (Sweden), Macclesfield (UK), and Durham (North Carolina, US). With a portfolio encompassing both small and large molecules, combination products, and groundbreaking technologies you will be a part of providing novel life-changing medicines to our patients around the globe.
Accountabilities
In this role you will develop and maintain in-depth knowledge of the quality regulations and guidelines applicable to the development and supply of drug products. You will also maintain an in-depth knowledge of the technologies and products and keep current with scientific changes and direction. You will ensure internal standards and processes impacting Product Quality meet external expectations and are enabled to support any change in technologies and products. You will facilitate the implementation and interpretation in aspects of the Pharmaceutical Quality System within your project portfolio. You will be accountable for the strategic Product Quality input into pharmaceutical project teams including technology transfer to Operations and contractors, and commercialization. This will include expertise in the products being supported and keeping up to date with related science and technology to ensure proactive and risk-based intrinsic and extrinsic Quality is built into the product. You will also provide Quality input into business, quality system, and product development projects.
Essential Skills/Experience
1. Bachelor’s degree in science and a minimum of 7 years of relevant experience or Master’s degree in science and a minimum of 5 years of relevant experience.
2. Extensive experience working within a pharmaceutical GMP Environment.
3. Working experience of drug development within a pharmaceutical development organization.
4. A broad and comprehensive understanding of Regulatory and Quality standards and Systems relating to the drug development process and experience of their application.
5. A comprehensive understanding of the pharmaceutical/drug development process.
6. Understanding of Project Management and Pharmaceutical Supply Chain processes.
7. Ability to make educated and inspiring decisions in complex situations.
8. Excellent team working, influencing, and networking skills.
9. Demonstrates independent judgement and uses risk management in complex situations.
10. Capable of making decisions, acting courageously, and communicating effectively with conviction and inspiration across interfaces.
11. Strong data-driven delivery and a continuous improvement mind-set.
12. Builds excellent relationships both internally and externally, preferentially with experience in Quality oversight and influencing of external manufacturing and testing organizations.
13. Demonstrates drive and energy in the role to make a difference and having a high degree of personal credibility.
Ready to make a difference? Apply now to join our team!
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