Senior Quality Engineer, GMP Compliance & eQMS Administration

Hubot, Inc. is an FDA-registered contract development and manufacturing organization (CDMO) serving global pharmaceutical and personal care brands — including Fortune 500 clients. With 25–30% projected year-over-year growth through 2030, we're building the infrastructure, systems, and team to match world-class ambition.

This position is not eligible for visa sponsorship.

Quality isn't just a department here — it's the foundation of everything we ship. We're looking for a Senior Quality Engineer to help us maintain that standard as we scale, bringing GMP expertise, sharp root-cause analysis skills, and hands-on eQMS experience to a team responsible for keeping our products safe, compliant, and audit-ready. You'll have real influence — from batch record review to leading our eQMS modernization — in an environment that rewards initiative and systems-level thinking.

• 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

• 7-9 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, Master Control, Track Wise, or similar)
• BA/BS in Engineering, Quality, Life Sciences, or related field

• 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

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

Join a team where safety isn’t a checkbox — it’s a competitive advantage.

Hubot, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.