Associate Director Pharmaceutical Quality Systems (Compliance)

Role Summary

Associate Director of Pharmaceutical Quality Systems (Compliance) – providing tactical and strategic leadership to manage critical compliance and quality systems programs, ensuring GMP adherence and driving continuous improvement; influence stakeholders and support inspections by customers, assessors, and regulators.

Responsibilities

• Compliance Leadership
• May have direct report responsibilities
• Demonstrate strong knowledge across major responsibilities and processes
• Act as execution lead/process owner for one or more processes
• Perform tasks related to a Senior Compliance Specialist
• Champion quality and compliance; communicate regulatory and industry trends
• Lead/improve quality systems/processes through cross-functional teams
• Expert understanding of cGMPs and Quality Systems
• Influence and negotiate at all organizational levels globally
• Develop others through coaching/mentoring
• Represent AstraZeneca in pharmaceutical professional associations
• Support preparation, planning, logistics, inspection management, and follow-up for inspections
• Collaborate with key operations customers for site Compliance Improvement Program
• Provide compliance expertise, consulting with customers to identify gaps and solutions
• Drive resolution of complex compliance issues
• Lead/participate in site Quality Management Review and other forums
• Design/develop/deliver site cGMP Training Programs
• Review/approve SOP changes
• Guide Data Integrity, Self-Inspection, and Quality Risk Management Programs
• Lead/participate in Regional and Global Forums
• Lead projects or participate on teams related to Compliance, Quality Systems, and improvement initiatives
• Supply/coordinate site documentation for new/revised Regulatory filings
• Implement revisions to global regulations/policies in AZ Global Quality and Compliance Manual
• Support validation/qualification and change control activities
• Support Compliance Director as designee or backup

Qualifications

• Required: Bachelor’s degree
• Required: Excellent oral and written communication skills
• Required: Strong ability and motivation to learn
• Required: Ability to collaborate and participate in multi-disciplinary teams
• Required: 7 years relevant experience in industry
• Required: Expert knowledge of global regulatory and cGMP requirements, industry best-practices
• Required: Demonstrated ability to work independently and collaboratively on multidisciplinary teams
• Required: Strong familiarity with production operations
• Required: Strong leadership, project management, and technical writing skills
• Required: Strong interpersonal, communication, and influencing skills
• Preferred: Bachelor’s degree in Science/technical field (Pharmacy, Biology, Chemistry or Engineering)
• Preferred: 7+ years in QA/Regulatory Compliance in pharmaceutical industry
• Preferred: Prior experience leading/regulatory inspections
• Preferred: Experience managing Quality Systems
• Preferred: ASQ certifications (CQA, CQE, CQM)
• Preferred: Active membership in ISPE, PDA, or similar

Skills

• Global regulatory and cGMP knowledge
• Quality Systems and data integrity focus
• Strategic and tactical leadership
• Cross-functional collaboration
• Regulatory inspection readiness and management