Lead Quality GMP Advisor - Site Quality

AstraZeneca UK

Location: Cheshire East

Job Type: Full time

Posted


Lead Quality Advisor


Are you ready to take the lead in ensuring patient safety and maintaining License to Operate across our Development functions? As the Lead Quality Advisor in Site Quality, you will be the prime source of GMP advice and leadership. You will interpret AZ regulatory and GMP standards into appropriate quality standards and provide guidance to ensure AstraZeneca and Regulatory requirements are met. This 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.

Accountabilities:
As a Lead Quality Advisor, 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 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.

Essential Skills/Experience:

  • Appropriate scientific degree with extensive experience (-10 years) of working within a pharmaceutical GMP environment, preferably within a pharmaceutical development organisation
  • Extensive experience from working in a Quality Assurance function
  • A broad and comprehensive understanding of Quality Systems and GMP
  • A comprehensive understanding of the pharmaceutical/drug development process
  • A detailed scientific understanding of the Product and technology types being supported
  • Good knowledge and reputation in the QA arena and specifically in GMP matters
  • Understanding of Supply Chain processes

Desirable Skills/Experience:

  • 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
  • Builds excellent relationships both internally and with external suppliers or service providers
  • Eligible QP preferred but not essential

At AstraZeneca, we take Quality seriously. Our work is important and valued. We are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. We draw learnings from others, to develop and understand what it takes to drive our modern mindset forward. Here you'll feel empowered to step up, follow the science and evidence to make decisions that put patients first. We are a team of ambitious people, who want to go far and we're all here to achieve. It's what drives us to be proactive and solutions-focused. At every stage of production, we step up and take accountability to deliver, each of us feeling responsible for the outcomes.

Are you ready to join a team that values quality, innovation, and patient-centricity? Apply now to be part of our Operations team as a Lead Quality Advisor!

Date Posted

22-lut-2024

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.