Digital & Data Quality (DDQ) GMP AI Compliance Director

Merck•Upper Gwynedd Township, PA

9d•Hybrid

About The Position

We aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our team and contribute to our mission of using the power of leading-edge science to save and improve lives around the world.

Requirements

Bachelor's degree in Science, Information Technology, Engineering, or equivalent (Advanced Degree preferred) with a 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.
Active Listening
AI Governance
AI Systems
Applied Engineering
Artificial Intelligence (AI)
Artificial Intelligence Software
Artificial Intelligence Techniques
cGMP Compliance
Change Management
Coaching
Communication
Data Integrity
Data Quality
Decision Making
Escalation Management
GMP Compliance
Information Communication Technology (ICT)
Interpersonal Relationships
Leadership
Listening Comprehension
Management Process
Manufacturing Quality Control
Operational Efficiency
People Leadership

Nice To Haves

Professional experience in culturally diverse environments.
Industry collaboration.
Lean Six Sigma, Project management (PMP), or other applicable professional certifications preferred.
Experience overseeing self-directed teams in carrying out day-to-day functions and assigning priorities and aligning reporting team(s) with strategic priorities.
Collaborative leadership style with an emphasis on listening, integrating diverse perspectives, coaching, and team building.
Experience in leading conversations during regulatory inspections.
Excellent communication and presentation skills.
Analytical problem-solving and root cause analysis skills.
Adaptability and decisiveness. Ability to respond to changing business priorities, technologies, and regulations.

Responsibilities

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.