Staff Quality Systems & Compliance Engineer

Multiply Labs • San Francisco, CA

3d • Onsite

About The Position

The Staff Quality Systems & Compliance Engineer is a foundational role within MLI’s Quality organization, owning the infrastructure that keeps our quality management system (QMS) running and our compliance posture inspection-ready. Reporting to the Head of Quality, this individual will be the operational owner of ZenQMS — MLI’s eQMS — and will lead day-to-day execution across all quality system programs including, but not limited to: document control, deviations/discrepancies, CAPA, change control, complaints, supplier quality, audits, data integrity, and management review. This is a hands-on, high-ownership role for someone who thrives on building systems from scratch and making them stick in a fast-moving, mission-driven environment.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Chemistry, or a related field.
• 6-8 years of quality systems or GxP compliance experience in CGT, biopharma, medical device, or contract development/manufacturing.
• Demonstrated hands-on experience administering an eQMS platform (ZenQMS, Veeva, MasterControl, or equivalent).
• Strong working knowledge of 21 CFR Part 11, EU Annex 11, ALCOA+, and GDocP principles.
• Experience conducting internal and/or supplier audits in a regulated GxP environment; familiarity with ISO 9001, ISO13485 or ISO 19011.
• Experience hosting or supporting external audits or regulatory inspections (customer audits, FDA, EMA, Notified Body, or equivalent).
• Experience owning quality program execution — not just supporting it — in a small or fast-moving team environment.
• Excellent technical writing and documentation skills with meticulous attention to detail.
• Comfortable operating with autonomy and building process where limited infrastructure exists.

Nice To Haves

• Direct experience with eQMS configuration and administration.
• Lead auditor certification (ISO 9001, ISO 13485, or equivalent).
• Background in equipment or software validation (IQ/OQ/PQ, CSV) in a GMP setting.
• Familiarity with robotic or automated manufacturing systems and associated quality challenges.
• ASQ CQA, CQE, or equivalent quality certification.
• Prior experience in a start-up or scale-up biotech company; comfort with ambiguity and rapid iteration.

Responsibilities

• Own configuration, administration, and continuous improvement of ZenQMS across all active and future modules.
• Train personnel on QMS processes including good documentation practices (GDP/ALCOA+), and ZenQMS workflows; serve as the internal subject matter expert for quality system tools.
• Manage the end-to-end NC/CAPA lifecycle.
• Administer the Change Control program, reviewing proposed changes for quality and regulatory impact, coordinating cross-functional approvals, and ensuring traceability.
• Maintain and report on key quality metrics: NC aging, CAPA on-time closure rate, overdue change controls — escalating trends to the Head of Quality.
• Support MLI’s 21 CFR Part 11 and EU Annex 11 compliance posture — including audit trail reviews, access control oversight, and periodic data integrity assessments.
• Maintain and operationalize the Data Integrity Policy program, including DI risk mapping methodology and audit trail review schedules.
• Identify compliance gaps and drive remediation through the QMS; contribute to regulatory readiness and customer audit preparation.
• Plan, lead, and execute internal quality audits across MLI’s QMS programs, operations, and facilities; document findings and drive timely CAPA closure in ZenQMS.
• Conduct supplier audits (on-site and remote) as part of MLI’s supplier management program.
• Support/host for external audits and regulatory inspections — including customer quality audits, partner assessments, and regulatory agency visits.
• Maintain the annual audit schedule and audit program metrics.
• Administer MLI’s supplier qualification and ASL program — coordinating supplier questionnaires, risk tiering, and qualification records.
• Assist with quality agreement reviews and supplier change notifications as needed.
• Coordinate and support the annual Management Review process — compiling quality metrics, preparing input reports, and maintaining review records in ZenQMS.
• Generate periodic quality performance dashboards and trend reports for the Head of Quality and senior leadership.
• Other activities as required in support of the quality department.

Benefits

• Competitive Compensation: Salary range of $140,000 - $185,000 plus meaningful early-stage equity.
• Premium Health: Premium Medical, Dental, and Vision plans with subsidies for child dependents.
• Wealth Building: 401(k) with a 4% company match.
• Pre-Tax Commuter Benefit.
• Parental Support: Robust Paid Parental Leave.
• Flexible PTO
• 12 Paid Holidays
• Referral bonuses

What This Job Offers

• Job Type: Full-time
• Career Level: Senior