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AstraZeneca

Global pharmaceutical company developing prescription medicines

Site Director - Development Quality

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeDurham, NC, USAIn-person

About the Job

Requirements

  • A relevant bachelor's degree or equivalent scientific or technical qualification, together with at least 10 years of experience in a pharmaceutical GMP environment.
  • Experience leading and developing teams.
  • Strong Quality Assurance leadership experience and a broad understanding of Pharmaceutical Quality Systems and GMP.
  • Strong understanding of the pharmaceutical development lifecycle and the different quality and regulatory considerations that apply as products progress through development.
  • Experience applying independent judgement and quality risk management to complex situations.
  • Confidence and communication skills to influence senior leaders and make and communicate difficult decisions clearly.

Responsibilities

  • Contribute as a member of the Development Quality Leadership Team, sharing responsibility with the Head of Development Quality and fellow leaders for setting and delivering the strategic direction of the function.
  • Partner with Quality leaders across the organisation to support an integrated and consistent approach to quality and compliance.
  • Act as a Quality Business Partner to senior Development leadership, delivering a patient-focused quality perspective to business decisions.
  • Lead responses to significant compliance issues, including issue management teams associated with complaints, recalls and other quality events, ensuring patient safety remains paramount while issues are effectively resolved.
  • Sponsor and lead functional and cross-functional quality improvement initiatives and ensure appropriate Quality Assurance input to major business improvement programmes.
  • Act as a recognised senior expert in Quality Systems, Quality Assurance and the application of GMP within Pharmaceutical Development.
  • Ensure high-quality and timely Quality input to development project and supply teams, enabling delivery of project milestones and reliable supply of investigational products and comparators to clinical trials.
  • Ensure appropriate Quality support for regulatory submissions and pre-approval inspections.
  • Drive consistent, science- and risk-based application of Quality Policy, GMP standards and quality practices across project and supply chain teams.
  • Ensure the site's pharmaceutical licence to operate is maintained, providing Quality leadership for regulatory authority interactions.
  • Build and lead the local site Quality team, driving performance and ensuring it has the capabilities to meet future needs.
  • Coach, develop and inspire talent within the leadership team and across Development Quality, creating an environment in which people can grow and perform at their best.
  • Establish effective ways of working and champion simplification and continuous improvement.
  • Deliver against agreed financial and headcount commitments while ensuring resources are focused on areas of greatest business and patient impact.

Desired Qualifications

  • Experience within Oral Solid Dosage and inhalation products.
  • Strong collaboration, networking and relationship-building skills across organisational and functional boundaries.
  • Ability to create effective teams and develop capability in others.
  • Strong facilitation skills and ability to build alignment around complex issues.
  • Ability to communicate with clarity, credibility and conviction at all levels of the organisation.
  • Experience leading change and continuous improvement.
  • Track record of setting high standards while creating an environment in which people can deliver at their best.
  • Energy, curiosity and ambition to continue developing the role and the wider Development Quality organisation.

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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