Senior Director, Development Clinical Quality (Americas)

AstraZeneca; Mississauga; Hybrid; CAD 120,000 - 160,000; Full time

Job summary

Join AstraZeneca's Development Quality Team as a Sr. Director, fostering a thriving quality culture while managing key relationships across Development, Regulatory, and Safety divisions. This role emphasizes leadership, improvement initiatives, and strategic risk management, ideal for candidates with significant industry experience and a life sciences background. You'll inspire excellence while becoming a vital part of our commitment to life-changing medicines.

Benefits

Flexible work environment

Employee growth encouragement

Diversity and inclusion commitment

Qualifications

• Over 15 years in clinical research with GCP and regulatory compliance expertise.
• Strong command over GxP/GCP regulations.
• Experience in risk assessments and CAPA management.

Responsibilities

• Mentor and lead a team of clinical quality business partners.
• Drive risk-based quality management with insights on GCP.
• Engage with senior leaders to foster a quality-driven mindset.

Skills

Clinical Research

GCP

Regulatory Compliance

Inspection Management

Strategic Planning

Education

Life Science Degree

Advanced Qualification

Job description

Unleash Your Potential with Us at Alexion, AstraZeneca Rare Disease

Join a dynamic environment where groundbreaking ideas meet the passion to inspire life-changing medicines. We believe that bringing diverse teams together fuels innovation and sparks extraordinary outcomes. That's why our team thrives on the power of in-person collaboration, working from the office at least three days a week, while also embracing flexibility and respecting individual needs. Dive into a world where ambition meets opportunity!

Your Impactful Mission:

As a pivotal member of the Development Quality Team, you'll be the catalyst for a thriving quality culture alongside stakeholders in Development, Regulatory, and Safety. Propel continuous improvement opportunities, shape strategic quality management initiatives, and manage influential business relationships. As a Sr. Director, you’ll mentor and lead a team of clinical quality business partners, guiding them towards excellence and fostering an environment of growth and innovation.

What You’ll Own:

• Leadership & Development: Propel a team of clinical quality business partners, nurturing their development and optimizing organizational performance.

• Strategic Excellence: Drive risk-based quality management with informed insights on GCP, aligning with our pioneering vision.

• Stakeholder Engagement: Forge strong alliances with senior leaders across Development, Regulatory, and Safety. Share your expertise and inspire a quality-driven mindset.

• Regulatory Expertise: Spearhead inspections and serve as a Subject Matter Expert on processes, quality governance, and more.

• Performance Leadership: Lead key meetings, driving quality culture and ensuring our high-reaching DQA organization's success.

• Innovation & Improvement: Bring change through continuous improvement, sharing insights, and learning from challenges to shape the future.

Your Skillset:

• A life science degree with an advanced qualification highly valued.
• Over 15 years in clinical research, with rich experience in GCP and regulatory compliance.
• Strong command over GxP/GCP regulations and guidelines like EMA, FDA, or PMDA.
• Expertise in inspection management, risk assessments, and CAPA management.
• Strategic planning skills with a knack for vision setting and tactical execution.

Empowered by Values:

• Integrity & Quality Orientation: Champion the highest standards in processes and compliance.

• Critical Thinking & Problem Solving: Navigate complex challenges with innovative solutions.

• Collaboration & Communication: Engage with curiosity and influence in a vibrant team setting.

This Role's Unique Foundation:

Be prepared to engage in transformative discussions, agile problem-solving, and dynamic collaboration throughout the day. Flexibility and adaptability will be your constant companions as you navigate new challenges and drive impact.

The Alexion Advantage:

Discover a workplace where your talents are valued, your growth is encouraged, and your purpose is clear. Join us at the forefront of rare disease research and make a lasting difference in patients' lives across the globe.

Ready to make an extraordinary impact? Take the leap and apply now to embark on a rewarding journey at Alexion, AstraZeneca Rare Disease.

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 11 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel

Are you interested in working at AZ, apply today!

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 [e-mail].

#LI-Hybrid

Date Posted

30-May-2025

Closing Date

13-Jun-2025

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lackthereof, sex, sexualorientation, age, ancestry, national origin, ethnicity, citizenship status, marital status,pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation, please contact [e-mail] . Alexion participates in E-Verify.