Regional Hub Director, Global Audit (US, Canada, Mexico)

Job Title: Regional Hub Director - Quality Audit, USA, Canada, and Mexico Hub

Location: Gaithersburg, MD or Wilmington, DE.

Introduction to the Role:

AstraZeneca’s commitment to quality is unwavering, and our Quality Audit team is central to ensuring the safety and efficacy of our life-changing medicines. As a Regional Hub Director for Quality Audit, you will lead efforts to maintain the highest standards across North America, ensuring compliance with global regulations and improving our operational excellence through advanced audit practices. In this vital role, you'll influence strategic directions, instilling a culture of quality and compliance that impacts patient outcomes and transforms healthcare.

Our global quality operations encompass key facilities in North America, tailored to support our strategic objectives and uphold our values of continuous improvement and innovation.

Key Responsibilities:

• Strategic Audit Leadership: Direct and execute complex audit strategies to ensure compliance with cGMPs, enhancing operational excellence across the region.

• Innovation in Quality Assurance: Champion cutting-edge audit methodologies and integrate modern quality systems that keep AstraZeneca at the forefront of the industry.

• Team Development and Leadership: Mentor and guide your audit team, fostering a culture of excellence and continuous improvement. Encourage high performance standards.

• Cross-Functional Collaboration: Engage with stakeholders across North America to enhance compliance, driving a collaborative culture that positively impacts operational and patient outcomes.

• Global Perspective: Work within our extensive network, coordinating with key facilities across North America to support AstraZeneca’s global quality mission.

Your work will include collaboration with Global Quality, Operations, Regulatory Affairs, and site management teams on specific projects, providing expert guidance on audit initiatives from planning through to implementation.

In this global role, you will drive adherence to quality assurance principles, champion compliance with regulatory standards, and ensure the execution of effective audit schedules and corrective actions while seeking opportunities to enhance operational quality.

Essential Skills & Experience:

• Significant experience in QA and pharmaceutical operations with advanced understanding of cGMP, audit skills, and proven leadership capabilities, with minimum of ten years of industry experience.

• Bachelor’s degree in a scientific discipline and minimum of five years of audit experience.

• Strong communication and interpersonal skills, both oral and written.

• Experience working in cross-cultural settings, with the ability to travel up to 40%, national and international.

• Proven ability to lead teams and manage complex projects within a global pharmaceutical environment.

Desirable Skills & Experience:

• Experience with international assignments or other intense cross-cultural responsibilities.

• Advanced degree in a scientific or business discipline.

• Experience in additional GXP areas (GLP, GCP).

At AstraZeneca, our collaborative environment fosters innovation and dedication. We value in-person collaboration, with an average of at least three days per week in the office, to connect, innovate, and excel together. We also recognize the need for flexibility to maintain a healthy work-life balance. Join us in our unique and dynamic world!

AstraZeneca supports and empowers its employees to make a difference, providing all the tools and resources needed to succeed in your career. Our culture of recognition and reward means you are always encouraged to take initiative and innovate. Ready to make a significant impact in quality assurance? Apply now!

The annual base pay for this position ranges from $174K to $261K. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered include