Associate Director – Medical Affairs Governance, Risk and Control

Responsibilities

• Lead the regulatory quality oversight program for Alexion Global Medical Affairs, including risk assessment, governance, and audit readiness.
• Develop and implement the Global Medical Affairs quality program regarding regulatory quality, monitoring, and reporting.
• Represent Global Medical Affairs in company regulatory quality forums and inspection preparation teams.
• Drive awareness of regulatory processes and quality management concepts across all functions of Global Medical Affairs.
• Collaborate with Process Owners and Subject Matter Experts to maintain regulatory quality processes and risk management initiatives.
• Oversee issue management, including root cause analysis, resolution design, and effectiveness checks.
• Implement and manage tools to track and report key quality metrics.

Requirements

• 10+ years of experience in the pharmaceutical/biopharmaceutical industry, medical, or life sciences.
• Minimum of 4 years of experience working in a quality role or managing quality systems.
• Deep knowledge of Post-Marketing and Clinical Trial regulations.
• Direct experience with GCP or GVP regulations.
• Educational background: Bachelors, PharmD, MD, PhD, NP, or MS in Life Sciences or a similar field.
• Strong leadership, problem-solving, and decision-making skills.

Preferred Qualifications

• Familiarity with Medical Affairs operations.
• MBA degree.
• Project Management certification or experience.

Benefits

• Competitive annual Variable Pay Bonus/Short Term Incentive opportunity.
• Eligibility to participate in equity-based long-term incentive programs.
• Competitive Flex Benefits & Retirement Savings Program.
• 4 weeks of paid vacation and annual Personal Days.

About the Company

AstraZeneca is a global, science-led biopharmaceutical company that focuses on discovering, developing, and commercializing prescription medicines. Through its Alexion business unit, the company continues to push the boundaries of science to deliver life-changing medicines to patients.