Associate Director Validation, Site Quality, Development Quality - Global Operations

Join us in our Site Quality Team!  We provide Quality oversight in the development of Investigational products and have the responsibility for Licence to Operate at our development site and play an important part in the commercialisation of new medicines. 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.

Are you ready to take the lead in ensuring patient safety and maintaining License to Operate across our Development functions? As an Associate Director in Site Quality you will be the prime source for quality/compliance advise in IT validation activities from a GMP perspective and provide quality leadership to Development functions. You will interpret AZ regulatory and GMP standards into appropriate quality standards and provide guidance to ensure AstraZeneca and Regulatory requirements are met. The role requires independent operation, risk management and lean skills, and decision-making against a background of varying regulations and standards. Your responsibility will extend to internal assets and GMP compliance decisions, having a major impact on AZ’s business.

Your role

As an Associate Director, you will develop and maintain in-depth knowledge of the quality regulations and guidelines applicable to your area. You will mentor and support junior colleagues, build strong customer relationships, and lead or participate in GxP audits/initiatives. You will also be responsible for developing and approving GMP documentation and QA risk assessments, providing Quality input into business improvement projects, and be part of external Regulatory Authority GMP inspections. You will work closely with the leadership teams of our customers to set strategic direction for quality within that area, maintaining quality oversight and driving continuous improvement.

Most appreciated in the role is the ability to lead projects, to improve processes or ways of working and support different functions with your subject matter expert knowledge. Working close to clinical trial manufacturing makes your role versified and enables lifelong learning in everyday tasks.

Essentials

• Appropriate scientific degree with extensive experience (5-10 years) of working within validation preferably in IT, in a pharmaceutical GMP environment.
• Extensive experience from working with all types of validation including, automation, computerized system and equipment.
• A broad and comprehensive understanding of Quality Systems and GMP.
• A comprehensive understanding of the pharmaceutical/drug development process.
• Builds excellent relationships both internally and with external suppliers or service providers.
• Good knowledge and reputation in the QA arena and specifically in GMP matters.

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.

Desirables

• Excellent team working and networking skills.
• Demonstrates independent judgement and uses risk management in complex situations.
• Capable of making decisions, acting courageously and communicating with conviction and inspiration.
• Demands excellence (sets high bar) and delivers.
• A good communicator with experience of interacting effectively across interfaces.
• Understanding of Supply Chain processes.
• A detailed scientific understanding of the Product types being supported.

Why AstraZeneca

At AstraZeneca, we take Quality seriously. Our work is important, valued, and at the forefront of discovery, development, and commercialization. We are always innovating, trialing the latest models and technologies to improve reliability and excellence in our processes. We are proactive, science-based, and driven by our ambition to go far. We are a team of ambitious people who want to achieve. We work together as a team, get our pipeline out to patients sustainably, reliably, and safely. We follow evidence to reach outcomes that benefit patients and AstraZeneca.

Make a difference! Apply now and join us in our journey to push the boundaries of science and make a real-life difference to patients.

Welcome with your application no later then 12th January, 2025.