Site Director, Development Quality

Regulatory Toolkit; Durham (NC); Hybrid; USD 142,000 - 213,000; Full time

Benefits offered by this job

Short-term incentives

Equity awards

Sales commissions

Retirement programs

Paid time off

Health benefits

Dental coverage

Vision coverage

Job summary

AstraZeneca is seeking a Site Director, Development Quality to lead the Quality organization at the Durham site, ensuring GMP standards and patient safety while enabling development teams to move with pace and confidence.

The role partners with Development and Supply Chain leadership globally to embed quality from the outset and drive science- and risk-based quality practices across projects and supply teams.

Qualifications

• Bachelor's degree or equivalent scientific/technical qualification with 10+ years in a pharmaceutical GMP environment.
• Experience leading and developing teams.
• Strong QA leadership with understanding of PQS and GMP.
• Solid grasp of pharmaceutical development lifecycle across projects.
• Ability to apply risk-based quality judgement to complex situations.

Responsibilities

• Lead Development Quality Leadership Team and set strategic direction for the function.
• Partner with Quality leaders across the organization for integrated quality and compliance.
• Act as Quality Business Partner to senior Development leadership.
• Lead response to significant compliance issues, recalls and quality events.
• Sponsor and lead quality improvement initiatives and QA input to major programs.
• Ensure QA support for regulatory submissions and inspections.

Skills

Quality leadership

GMP expertise

Stakeholder influence

Quality systems

Regulatory knowledge

Education

Bachelor's degree or equivalent

Job description

The Site Director, Development Quality is a senior leadership role with a significant opportunity to influence how Quality enables the delivery of our exciting development portfolio. At its heart, the role is about protecting patients, ensuring GMP standards are met at the site while creating an environment in which quality enables development teams to move with pace, confidence and appropriate risk management. The Site Director provides Quality leadership at the site and contributes to the strategic direction of Development Quality globally.

As a Quality leader, the role partners with leaders across Development and Supply Chain globally, helping teams build quality in from the outset and achieve business outcomes in compliance with internal standards and external regulatory requirements.

The Site Director also plays an important role in shaping our Quality culture. They set high standards for Quality Leadership, building a Development Quality organization that is recognized as an influential, proactive and valued business partner. Operating with a high degree of independence, the Site Director makes complex quality and compliance decisions that can have significant implications for development projects. This requires sound judgement and the ability to navigate evolving regulatory expectations and the different requirements associated with each stage of pharmaceutical development.

Accountabilities

Development Quality leadership

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 patient-focused quality perspective to business decisions.
• Lead the response 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 and 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 any regulatory authority interactions.

People and organisational leadership

• Build and lead the local site Quality team, driving performance and ensuring it has the capabilities to meet the future.
• Coach, develop and inspire talent, both 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 the areas of greatest business and patient impact.

Essential Skills/Experience

We're looking for an experienced Quality leader who combines deep technical credibility with the ability to lead people, influence senior stakeholders and make sound science and risk-based decisions in complex situations. You will bring:

• A relevant bachelor's degree or equivalent scientific/technical qualification, together with at least 10 years of experience in a pharmaceutical GMP environment. Experience within Oral Solid Dosage and inhalation products would be particularly valuable.
• Experience of 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.
• The confidence and communication skills to influence senior leaders and make and communicate difficult decisions clearly.

Desirable Skills/Experience

Ideally, you will also demonstrate:

• Strong collaboration, networking and relationship-building skills across organisational and functional boundaries.
• The ability to create effective teams and develop capability in others.
• Strong facilitation skills and the ability to build alignment around complex issues.
• An ability to communicate with clarity, credibility and conviction at all levels of the organisation.
• Experience leading change and continuous improvement.
• A 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

The annual base pay (or hourly rate of compensation) for this position ranges from$141,997.6to$212,996.4 USD. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coveragein accordance withthe terms of the applicable plans.

AstraZenecais an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [e-mail].

Why AstraZeneca

Join a place where you are trusted to take ownership and move fast, combining scientific rigor with data-driven operations to deliver therapies that change lives. You will work shoulder-to-shoulder with unexpected teams in the same room, unleashing bold thinking to solve complex logistics challenges at scale. We champion curiosity and decisive action, value kindness alongside ambition, and empower you with the tools, partnerships, and freedom to shape how living medicines reach patients across the world.

Date Posted

22-Oct-2026

Closing Date

29-Nov-2026

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Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.