Senior Director, Development Clinical Quality (Americas)

AstraZeneca GmbH; Mississauga; Hybrid; CAD 130,000 - 180,000; Full time

Job summary

A leading company in rare disease research is seeking a Sr. Director for their Development Quality Team. In this role, you will propel a thriving quality culture, engage with key stakeholders, and mentor a team of clinical quality partners while driving strategic excellence in regulatory compliance.

Benefits

Diversity and inclusion commitment

Flexibility in work environment

Qualifications

• Over 15 years in clinical research with strong experience in GCP.
• Expertise in GxP/GCP regulations and guidelines like EMA, FDA.
• Strong strategic planning and vision-setting skills.

Responsibilities

• Lead clinical quality business partners and drive quality culture.
• Engage with senior leaders across Development, Regulatory, and Safety.
• Spearhead inspections and serve as Subject Matter Expert.

Skills

GCP and regulatory compliance

Inspection management

Risk assessments

CAPA management

Strategic planning

Education

Life science degree with 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

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.