Pharma Manufacturing & QA SME with AI Workflow exp - 100% REMOTE

Role Overview

We are seeking an experienced Pharmaceutical Manufacturing / Quality SME to provide practical guidance on AI-enabled workflows within regulated GMP environments. The SME will validate proposed AI use cases against real-world manufacturing and quality practices, ensuring workflows are operationally realistic, compliant, and appropriately designed for human oversight.

Key Areas of Expertise

• 1. Deviation & CAPA Triage
• Advise on streamlining deviation and CAPA exception logging and triage.
• Validate evidence requirements for quality records and escalation decisions.
• Review practical escalation pathways and sponsor notification tracking.
• Identify opportunities and limitations for AI-assisted quality event management.
• 2. Autonomous Batch Record Review
• Evaluate AI workflows designed to accelerate batch record review and disposition.
• Identify practical release blockers and critical reviewer checks.
• Define where review-by-exception can realistically be applied within GMP environments.
• Validate cycle-time and operational assumptions for AI-assisted batch review.
• 3. TMF / Inspection Readiness Agent
• Advise on AI workflows that cross-reference quality, MES, training, and related systems.
• Identify potential record drift, inconsistencies, and contradictions before regulatory inspections.
• Define practical approaches to inspection readiness and quality-data reconciliation.

Responsibilities

• Validate proposed AI workflows against real-world GMP manufacturing and QA practices.
• Define appropriate regulatory and human-in-the-loop boundaries for AI-enabled processes.
• Sanity-check workflow assumptions, operational feasibility, and expected cycle-time improvements.
• Provide practical SME feedback based on hands-on experience in pharmaceutical manufacturing and quality operations.
• Identify risks, gaps, and practical considerations that may not be apparent from a purely technology-focused perspective.

Ideal Candidate Profile:

• Senior Pharma Manufacturing, QA, or Quality Operations leader with strong GMP experience.
• Background in Cell & Gene Therapy (CGT), Biologics, or pharmaceutical manufacturing.
• CDMO experience strongly preferred.
• Hands-on experience with Veeva Vault QMS.
• Experience with MES platforms such as Körber PAS-X.
• Strong understanding of:
• Deviations and CAPA
• Batch record review and disposition
• GMP documentation and data integrity
• Regulatory inspections and inspection readiness
• Quality systems and manufacturing execution systems
• Ability to translate practical manufacturing/quality processes into requirements for AI and agentic workflows.
• Comfortable challenging assumptions and explaining how processes work in practice, rather than only from a strategic or theoretical perspective.