Site Director, Development Quality

AstraZeneca plc; Durham (NC); Presencial; USD 142.000 - 213.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health, dental, and vision coverage

Retirement programs

Paid time off

Descripción de la vacante

AstraZeneca is seeking a Site Director, Development Quality in Durham, NC to lead the site quality organization and partner with global Development Quality. You will ensure GMP compliance, enable development teams to move with pace, and support regulatory interactions while shaping a proactive quality culture.

The role drives quality leadership for investigations, risk management, and continuous improvement, with accountability for the site’s licence and successful inspections.

Formación

• 10+ years in pharma GMP with quality leadership experience.
• Proven ability to lead cross-functional teams and drive quality improvements.
• Strong regulatory understanding for development lifecycle and inspections.

Responsabilidades

• Lead Development Quality at site ensuring GMP compliance and patient safety.
• Partner with global leadership to align quality strategy across Development.
• Drive quality risk management and issue resolution for major projects.
• Support regulatory submissions and pre-approval inspections.
• Build and develop the site Quality team and budget delivery.

Conocimientos

Leadership

Quality Assurance

GMP

Regulatory knowledge

Stakeholder management

Team development

Educación

Bachelor's degree in science or related field

Herramientas

Quality Systems (GxP)

Descripción del empleo

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

• 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

• 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

• 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

Where can I find out more?

• Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
• Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
• Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
• Our US Footprint: Powering Scientific Innovation - YouTube

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.

AstraZeneca is 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].

The annual base pay (or hourly rate of compensation) for this position ranges from $141,997.6 to $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 coverage in accordance with the terms of the applicable plans.

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.