Associate Director Pharmaceutical Quality Systems (Compliance)

Role Summary

Associate Director of Pharmaceutical Quality Systems (Compliance) provides tactical and strategic leadership within operations or sites to manage critical compliance and quality systems programs, ensuring adherence to GMP requirements and driving continuous improvement. Influences stakeholders and supports inspections by external customers, internal assessors, and regulatory authorities.

Responsibilities

• Compliance Leadership
• May have direct report responsibilities
• Demonstrated strong knowledge and expertise in major responsibilities and processes
• Act as execution lead/process owner for one or more processes
• Perform tasks related to a Senior Compliance Specialist
• Champion of quality and compliance; communicate regulatory and industry trends
• Lead/driving improvements to 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 pharmaceuticals professional associations
• Support preparation, planning, logistics, inspection management, and follow-up for inspections
• Collaborate with/influence key operations customers for site Compliance Improvement Program
• Provide compliance expertise, consulting with customers to identify gaps and recommend 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 Program, Self-Inspection Program, and Quality Risk Management Program
• 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

• Bachelor‚Äôs degree
• Excellent oral and written communication skills
• Strong ability and motivation to learn
• Ability to collaborate and participate in multi-disciplinary teams
• 7 years relevant experience in industry
• Expert knowledge of global regulatory and cGMP requirements, industry best-practices
• Demonstrated ability to work independently and collaboratively on multidisciplinary teams
• Strong familiarity with production operations
• Strong leadership, project management, and technical writing skills
• Strong interpersonal, communication, and influencing skills

Desirable Qualifications

• Bachelor‚Äôs degree in a Science/technical field such as Pharmacy, Biology, Chemistry or Engineering
• 7+ years in QA/Regulatory Compliance in the pharmaceutical industry
• Prior experience leading/managing regulatory inspections
• Experience managing Quality Systems
• ASQ certifications (e.g. CQA, CQE, CQM)
• Active member of pharmaceutical trade associations such as ISPE, PDA, etc.