Audit QA Manager, R&D Quality Assurance

Cambridge, England, Cambridgeshire
24 May 2021
21 Jun 2021
Quality, Auditor, GCP
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Do you have expertise in, and passion for, Quality Assurance? Would you like to apply your expertise to impact the quality assurance in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca 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!

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 attitude for the benefit of our patients.

The Oncology R&D function is a place built on courage, curiosity and collaboration - we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team.

What you'll do

  • The QA Manager, Quality Assurance Audit is responsible for:
    • Planning, leading, conducting and reporting audit activities for R&D GCP or GVP risk-based audit programs
    • Support of GCP or GVP inspection activities
    • Management of CAPAs related to audit and/or inspection findings in collaboration with QA colleagues and functions owning the issues.
    • Support of AUDIT QA activities such as CAPA tracking & follow-up.

The ideal candidate would have experience in auditing GCP and Pharmacovigilance systems globally.

Essential for the role
  • Degree level education or equivalent
  • Experience in pharmaceuticals or a related industry
  • Excellent analytical, written and oral communications skills
  • Fluent in written and spoken English
  • High ethical standards, trustworthy, operating with absolute discretion
  • Strong collaborative, influencing and social skills - curious to understand business environment
  • Skilled at managing & using technology
  • Ability to maintain and build professional networks with partners
Desirable for the role
  • Audit Experience
  • Experience in supporting regulatory health authority GxP Inspections
Location: Cambridge, UK / Gaithersburg, US / Gothenburg, Sweden 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 imagining yourself joining our team? Good, because we can't wait to hear from you.
  • We welcome your application, no later than (April) (20th, 2021)
Where can I find out more

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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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