Product Quality Lead - Development Quality
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 organisations. Be part of a distributed team of Product Quality professionals embedding Quality from Development to commercialisation. The role involves interpreting external regulatory requirements and expectations into appropriate quality standards and ensuring their application by providing direction to the relevant organisations.
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 expectation 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 commercialisation. This will include an 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
Relevant scientific degree with extensive experience of working within a pharmaceutical GMP Environment.
Working experience of drug development within a pharmaceutical development organisation.
A broad and comprehensive understanding of Regulatory and Quality standards and Systems relating to the drug development process and experience of their application.
A comprehensive understanding of the pharmaceutical/drug development process.
Understanding of Project Management and Pharmaceutical Supply Chain processes.
Ability to make educated and inspiring decisions in complex situations.
Excellent team working, influencing, and networking skills.
Demonstrates independent judgement and uses risk management in complex situations.
Capable of making decisions, acting courageously, and communicating effectively with conviction and inspiration across interfaces.
Strong data-driven delivery and a continuous improvement mind-set.
Builds excellent relationships both internally and externally.
Demonstrates drive and energy in the role to make a difference and having a high degree of personal credibility.
You thrive when you work independently, when leading projects and take pride in structuring your day, knowing that the diverse workload can change the schedule with little notice. You are a problem solver who can look at solutions in a pragmatic way – coming up with creative solutions whilst still following our strict regulations.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, we champion a mindset of excellence. We search for opportunities to add value, harnessing science and evidence to foresee risk. Our environment encourages continuous innovation to find new ways to improve outcomes for patients. Here, you'll feel empowered to step up, follow the science, and make decisions that put patients first.
Ready to make a difference? Apply now!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
