Digital & Data Quality Compliance Director

Role Overview

• Keep abreast of emerging regulatory trends pertaining to AI use in GMP/GDP operations
• Define and implement standards for GMP/GDP use of AI-based tools and applications, including data management, quality risk management, vendor assessment, human-in-the-loop role, technology-specific requirements, data retention, and periodic monitoring
• Sponsor and, where appropriate, lead development of policies and procedures for validation and monitoring of GMP/GDP AI-based tools and applications
• Partner with relevant stakeholders across our manufacturing division, our research & development division, and IT to develop common frameworks and champion use of common solutions across the divisions
• Collaborate with relevant stakeholders and provide input into GMP classification, risk assessment, validation, and monitoring strategies for AI-based tools and applications proposed for use at our manufacturing division
• Provide and/or coordinate quality oversight of GMP AI-based tools and applications to ensure validation efforts focus on intended use and maintaining the validated state, including human-in-the-loop role, periodic monitoring, output reliability, and explainability
• Actively drive and participate in external engagements to benchmark and align with industry peers
• Experiment with AI technologies and pursue opportunities to employ AI-based tools in DDQ operations
• Contribute to the DDQ strategy, team development, and continuous improvement of DDQ-owned processes as a member of the DDQ Leadership Team
• Manage escalations effectively and efficiently
• Manage DDQ resources, participate in hiring, training, and management of DDQ departmental employees, coach direct reports and other team members, and align team and individual goals with departmental and company objectives
• Model and reinforce our company’s leadership behaviors, values, and culture.

Requirements

• Bachelor's degree in Science, Information Technology, Engineering, or equivalent (Advanced Degree preferred)
• minimum of twelve (12) years’ global and site experience in an FDA and/or EU regulated pharmaceutical, vaccine, biologics, or API manufacturing environment
• Expert knowledge of relevant regulations (FDA/EU/ICH/WHO), with emphasis on emerging AI regulations and guidance; 21 CFR Part 11, 210, 211, EU Annex 11 and Annex 15, data integrity, and local regulatory expectations as well as industry standards, such as GAMP
• Thorough understanding of current regulatory trends in GMP AI, data integrity, and computerized systems
• Extensive knowledge of the principles of quality risk management and data management
• Proven track record of formulation and implementation of validation strategies for novel technologies
• Understanding of a range of AI technologies, model performance assessments, explainability techniques, and model monitoring tools (hands-on experience preferred)
• Business engagement skills, with the ability to collaborate with both technical and non-technical roles
• Proficiency in negotiation, facilitation, building cross-functional relationships, and influencing others
• Training and coaching skills.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days