Senior Quality Manager - Regulatory & eQMS Lead

Hubot | Tri Pac, Inc. CDMO; South Bend (IN); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

401(k) plan

Paid time off

Job summary

Hubot, Inc. in South Bend, Indiana, seeks a Senior Quality Engineer for a full-time, on-site role reporting to the Director of Technical, Analytical & Innovation.

The candidate will deepen GMP-compliant systems, lead CAPA and deviation investigations, and oversee eQMS modules to support FDA and ISO audits. You bring 12–15 years in a GMP environment, hands-on with eQMS platforms (Veeva Vault, MasterControl, TrackWise), and a BA/BS in Engineering, Quality, Life Sciences, or related field.

Qualifications

• 12-15 years in a GMP-regulated environment pharma, personal care, or chemical manufacturing.
• Working knowledge of FDA 21 CFR 210/211, ISO 9001, ISO 22716, and 21 CFR Part 11.
• Hands-on experience with eQMS platforms (Veeva Vault, MasterControl, TrackWise, or similar)
• BA/BS in Engineering, Quality, Life Sciences, or related field

Responsibilities

• Lead failure investigations using root cause analysis tools and drive CAPA implementation
• Review Batch Records, SOPs, and change controls for GDP compliance and regulatory alignment
• Evaluate proposed process and design changes for change control requirements
• Monitor and implement procedures related to Quarantine, Hold, Expired, Damaged, Return Goods, and Recalled product
• Provide routine analysis of KPIs and quality performance indicators; identify trends
• Support risk management file updates for process changes; implement process controls and error-proofing measures
• Collaborate with functional process owners to train, mentor, and facilitate QMS requirements and continuous improvement
• Support and administer eQMS modules CAPA, document control, deviation management, audit management, and training records
• Contribute to eQMS upgrade, validation, and ongoing maintenance; support process, equipment, and method validation activities as required; ensure 21 CFR Part 11 compliance and audit trail integrity
• Support internal audit programs and assist in preparation for FDA, ISO, and customer audits

Skills

GMP compliance

CAPA

Root cause analysis

eQMS leadership

Education

BA/BS in Engineering, Quality, Life Sciences, or related field

Tools

eQMS platforms (Veeva Vault, MasterControl, TrackWise)

Job description

Hubot, Inc. in South Bend, Indiana, seeks a Senior Quality Engineer for a full-time, on-site role reporting to the Director of Technical, Analytical & Innovation.

The candidate will deepen GMP-compliant systems, lead CAPA and deviation investigations, and oversee eQMS modules to support FDA and ISO audits. You bring 12–15 years in a GMP environment, hands-on with eQMS platforms (Veeva Vault, MasterControl, TrackWise), and a BA/BS in Engineering, Quality, Life Sciences, or related field.