Associate Director, Risk Based Quality Management

Are you ready to lead the charge in Risk Based Quality Management (RBQM) and make a significant impact on clinical trials? As an Associate Director, RBQM, you'll drive the RBQM process in assigned studies or projects, ensuring compliance with ICH-GCP R2, Guidelines, and SOPs.

Your role is pivotal in safeguarding clinical trial integrity and patient safety. Collaborate closely with Global Project and Study teams, Senior Specialists RBQM, and Clinical Data Scientists to define critical quality factors and risk management strategies. You'll oversee the central monitoring team, contribute to standardization, and define best practices. Your proactive approach will be key in sharing insights and experiences, implementing process improvements, and ensuring an integrated cross-functional approach to managing quality in clinical study conduct.

Accountabilities

• Lead the RBQM process and centralized monitoring in eligible studies.
• Engage with project teams during initial study stages to implement a Quality by Design (QbD) approach.
• Act as a subject matter expert in RBQM and risk management.
• Contribute to cross-functional innovation and optimization projects.
• Maintain a current understanding of regulatory requirements and industry trends.
• Develop, coach, mentor, and encourage individuals within the CM organization.
• Oversee activities performed by junior RBQM team members.
• Lead or serve as a guide for innovating CM methodology and guidelines.
• Identify gaps and lead initiatives to promote new ways of working.

Essential Skills/Experience

• A BSc degree in Life Science is required with 8-10+ years of experience in the Biotech/Pharma/CRO industry. Candidates should be passionate about Quality Management and have 3 years of experience in risk assessment or a related area.
• Deep understanding of clinical development and risk-based monitoring methodologies.
• Ability to define and lead improvement projects and interact with senior management.
• Excellent communication skills in English.
• Strong Project Management and Risk Management skills.
• Ability to mentor, train, and lead teams.
• Responsiveness to industry needs and embracing peer review.
• Strong cross-functional leadership skills.
• Ability to operate in a volatile, uncertain, complex, and ambiguous environment.

Desirable Skills/Experience

• A master's degree or PhD in a related science field.
• Certification in Quality Risk Management or Project Management.
• Experience leading study teams and maintaining oversight of complex studies.
• Good understanding of molecule and disease area strategies.
• Experience with advanced analytics approaches (e.g., machine learning/AI).
• Fluency in programming languages (SAS, R, Python, SQL).

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, you'll find an environment where innovation thrives. Our commitment to rare diseases means your work will have a profound impact on patients' lives. With a rapidly expanding portfolio, you'll enjoy the entrepreneurial spirit of a leading biotech while being supported by a global biopharmaceutical leader. Our culture fosters connections, encourages new ideas, and supports your growth through tailored development programs. Join us in making a difference for those living with rare diseases.

Ready to take the next step? Apply now to join our team!

Date Posted

Closing Date

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 lack thereof, sex, sexual orientation, 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 an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.