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AstraZeneca

Global pharmaceutical company developing prescription medicines

Director Product Quality

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeLiverpool, UKNo salary listed

About the Job

Requirements

  • A Bachelor of Science degree in Biology, Biochemistry, Chemistry, Engineering, or equivalent experience in a related field.
  • Experience in multiple areas of quality assurance within a pharmaceutical manufacturing environment.
  • Confirmed work experience in Quality.
  • Experience interacting with global Regulatory Bodies.
  • Solid understanding and application of CMC-related regulatory guidances, such as ICH, FDA, EMA, and MHRA.

Responsibilities

  • Represent Quality on global teams as the liaison for the entire Quality function for the Flu Franchise and other products, ensuring alignment and clear decision-making that protects patients and supply.
  • Support the Flu Franchise governance team and drive effective information flow to CMC, Quality Product Teams, and site quality leads, translating strategy into phase-appropriate execution.
  • Act as the communication bridge between development, CMC, Quality, and Operations to remove barriers, synchronize priorities, and secure right-first-time outcomes.
  • Engage collaborators to implement CMC strategies and escalate Quality constraints early, enabling faster cycle times and robust product plans.
  • Maintain Quality understanding from cell and viral banking through post-release events, connecting critical control points to patient outcomes.
  • Provide data-driven, phase-appropriate Quality advice to the CMC Team to manage risk proactively and enable confident decision-making.
  • Review and approve regulatory filings as needed, safeguarding compliance and supporting successful submissions globally.
  • Lead the Quality Product Team to resolve product quality challenges and capitalize on opportunities that strengthen robustness and supply.
  • Contribute to development procedures in the area of specialism and provide technical input into global standards to drive consistency and excellence.
  • Identify opportunities to enhance business processes and Quality systems, championing Lean ways of working that raise productivity and quality outcomes.
  • Participate in external engagement to shape CMC strategies and reflect best practice back into company standards.
  • Support and mentor colleagues across the wider Quality team, building capability and a culture of accountability and kindness.

Desired Qualifications

  • A postgraduate qualification.
  • An advanced degree in a related field or equivalent experience.
  • Previous method development, process development, regulatory affairs CMC, or formulation development experience.
  • Eligibility for QP status and preference for eligibility to be named on the UK site license.
  • Understanding of egg-based flu manufacturing processes and analytics.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

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