Senior Quality Manager

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 HubotHubot, 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.⭐ 4.8 Glassdoor | 4.7 Indeed | 95% Employee Recommendation Rate. 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 DoLead failure investigations using root cause analysis tools (5-Why, Fishbone, FMEA) and drive CAPA implementationReview Batch Records, SOPs, and change controls for GDP compliance and regulatory alignmentEvaluate proposed process and design changes for change control requirements, guide qualification and validation criteriaMonitor and implement procedures related to Quarantine, Hold, Expired, Damaged, Return Goods, and Recalled productProvide routine analysis of KPIs and quality performance indicators; identify trendsSupport risk management file updates for process changes; implement process controls and error-proofing measuresCollaborate with functional process owners to train, mentor, and facilitate QMS requirements and continuous improvementSupport and administer eQMS modules CAPA, document control, deviation management, audit management, and training recordsContribute 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 integritySupport internal audit programs and assist in preparation for FDA, ISO, and customer audits What You Bring12-15 years in a GMP-regulated environment pharma, personal care, or chemical manufacturingWorking knowledge of FDA 21 CFR 210/211, ISO 9001, ISO 22716, and 21 CFR Part 11Hands-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✅ CAPA closure rate on time ≥ 95%✅ 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 OfferCompetitive base salary commensurate with experienceMedical, dental, and vision insurance401(k) with company contributionPaid time off and holidays Apply TodayCome do science that ships. Real products. Real clients. Real impact. 🌐 www.hubot.us Hubot, Inc. is an Equal Employment Opportunity / Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status