Associate Director – Supplier Qualification Programme Lead

Do you have expertise in the role of supplier assessment and qualification in a GCP environment? Do you have a passion for promoting and optimising quality and efficiencies? Do you enjoy providing data-driven insights? Then this role might be the one for you!

About AstraZeneca

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.

Business area

As the independent second line assurance function for R&D, our mission in Quality Assurance is to achieve enduring excellence in auditing, quality management, quality risk assessment and enhance the R&D quality approach for the benefit of patients.

R&D QA commits to provide our partners with an experience that is driven by patient protection and data integrity, represents regulators current and future views, optimises quality thinking and promotes a ‘right from me’ approach, focuses on issues that matter, minimises risks and drives inquisitive outcomes and provides simple, structured and efficient systems, with up-to-date quality information.

Come and join our AZ team where you will play a pivotal role in this exciting period of development!

What you’ll do

  • Be part of a dynamic, global, multi-disciplinary team responsible for the continued development of Astra Zeneca R&D’s supplier qualification and audit process.

  • Have ownership of and be responsible for the development and enhancement of the R&D QA GCP Supplier Qualification and audit programme.

  • Be part of a team planning, leading, conducting and reporting supplier qualification assessments and audit activities for GCP and GLP suppliers.

  • Devise strategies to assess and quantify gaps and risks associated with potential and existing suppliers and advise on suitable mitigations.

  • Analyse Quality data for proactive risk assessments of suppliers to govern audit approaches and for presentation at quality review meetings

  • Run significant CAPAs and quality issues related to supplier audit and/or inspection findings in collaboration with functions leading the issues.

  • Establishment and management of QA – QA agreements with key suppliers

  • Work with Process Owners, business areas and IT to design, implement, govern and refine industry-leading tools and processes for remote supplier assessments.

  • Establish, monitor and report Quality Key Performance Indicators and metrics to meet business needs and regulatory requirements, in collaboration with functional and therapeutic area customers.

  • Provide supplier audit and qualification support for regulatory inspections and investigations.

Required Experience, Skills, and Qualifications

  • Degree level education or equivalent experience

  • Experience in pharmaceuticals or a related industry especially the GCP area

  • Excellent analytical, written and oral communications skills

  • High ethical standards, honest, operating with absolute discretion

  • Strong collaborative, influencing and interpersonal skills – curious to understand business environment

  • Skilled at managing & using technology

  • Ability to maintain and create professional networks with collaborators

Desired requirements

  • Project management experience

  • Experience in leading regulatory health authority GxP Inspections

  • Key Account management

  • Audit expertise

  • Supplier qualification

Why AstraZeneca

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next:

Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you.

Competitive salary and benefits package on offer.

The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package.

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