Senior Quality Manager

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

Senior Quality Engineer Hubot, Inc. South Bend, Indiana | Full-Time

On-Site

Reports to: Director of Technical, Analytical & Innovation

This position is not eligible for visa sponsorship.

About Hubot

Hubot, Inc. is an FDA-registered contract development and manufacturing organization (CDMO) specializing in liquids, semi solids and aerosol filling for global pharmaceutical and personal care brands including Fortune 500 clients. We develop and manufacture products that reach consumers across the world, and our analytical laboratory is central to making that happen safely, accurately, and on time.

Why Hubot ?

Growth-Stage Opportunity We're forecasting 25–30% year-over-year revenue growth through 2030. This is a rare chance to join a scaling CDMO where your contributions directly shape laboratory capabilities not just maintain them.

Real Client Impact You'll work on products that ship to Fortune 500 pharmaceutical and personal care brands. Your analytical work isn't academic it releases product, supports regulatory submissions, and protects patients and consumers.

Regulated Industry Depth Our laboratory operates under FDA 21 CFR 210/211, ISO 13485, ISO 9001, ISO 14001 and ISO 22716 cGMP standards. You'll sharpen expertise in frameworks that are valued across the global pharmaceutical and personal care supply chain.

Ownership Over Systems, Not Just Instruments You'll hold supervisory sign-off authority in LIMS, author the SOPs your team works from, and drive method development from concept through validation with real technical autonomy.

This is a role for a seasoned quality professional who has spent 10+ years working hands‑on with OOS (Out of Specification) investigations, CAPA (Corrective and Preventive Action), deviation management, root cause investigations, Annual Product Reviews (APR), and audits — and who is now ready to bring that depth of experience into a role focused on strengthening systems, processes, and compliance frameworks rather than validation activities.

What You'll Do

• Lead failure investigations using root cause analysis tools (5-Why, Fishbone, FMEA) 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, guide qualification and validation criteria
• 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

What You Bring

• 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

How We Measure Success

• GDP adherence on batch record and SOP reviews ≥ 98%
• eQMS module uptime and audit trail integrity 100%
• Internal audit findings closed within defined timelines ≥ 90%
• At least one eQMS process improvement or automation implemented By Month 9

What We Offer

• Competitive base salary commensurate with experience
• Medical, dental, and vision insurance
• 401(k) with company contribution
• Paid time off and holidays

Hubot, Inc. is an Equal Employment Opportunity / Affmprian Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status