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

Position: Pharma Manufacturing SME – GMP / AI Workflow Advisor

Duration: 3-4 Months

Location: 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.
 

Best Regards,

Chetna

Truth Lies in  Heart