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

Smart Caliber Technology; United States; Remote; USD 83,000 - 152,000; Full time

Job summary

Smart Caliber Technology seeks a Pharma Manufacturing SME to guide AI-enabled workflows in GMP settings. This 3–4 month, 100% remote engagement focuses on deviation/CAPA triage, autonomous batch record review, and TMF/inspection readiness.

The role validates workflows against real-world manufacturing and quality practices, ensuring human oversight and regulatory alignment. The ideal candidate has senior GMP operations experience, strong knowledge of QA processes, and hands-on exposure to Veeva

Qualifications

• Advise on streamlining deviation and CAPA logging.
• Validate evidence requirements for quality records and escalation decisions.
• Review escalation pathways and sponsor notification tracking.
• Identify opportunities and limitations for AI-assisted quality event management.

Responsibilities

• Validate proposed AI workflows against real-world GMP manufacturing and QA practices.
• Define regulatory and human-in-the-loop boundaries for AI-enabled processes.
• Sanity-check workflow assumptions, feasibility, and cycle-time improvements.
• Provide SME feedback from hands-on pharma manufacturing and quality operations.
• Identify risks and gaps not apparent from a purely technology perspective.

Skills

Deviation & CAPA triage

Autonomous batch record review

TMF / inspection readiness

Job description

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