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Salary: USD 140,000 - 185,000 / annual
Multiply Labs is seeking a Staff Quality Systems & Compliance Engineer to serve as the operational owner of the company's quality management system (QMS) and eQMS platform. Reporting to the Head of Quality, this is a foundational, high-ownership role responsible for building and maintaining the infrastructure that keeps quality systems running and the organization inspection-ready.
Key Responsibilities:
Quality Systems: 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.
Non-Conformance, CAPA & Change Control: Manage the end-to-end non-conformance/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 including NC aging, CAPA on-time closure rate, and overdue change controls.
Compliance & Data Integrity: Support 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. Identify compliance gaps and drive remediation through the QMS.
Audits & Inspection Management: Plan, lead, and execute internal quality audits across QMS programs, operations, and facilities. Conduct supplier audits (on-site and remote). Support and host external audits and regulatory inspections including customer quality audits and regulatory agency visits. Maintain the annual audit schedule and audit program metrics.
Supplier Quality: Administer supplier qualification and Approved Supplier List (ASL) program, coordinating supplier questionnaires, risk tiering, and qualification records. Assist with quality agreement reviews and supplier change notifications.
Management Review & Quality Reporting: Coordinate and support the annual Management Review process, compiling quality metrics and preparing input reports. Generate periodic quality performance dashboards and trend reports for leadership.
This is a hands-on role for someone who thrives on building systems from scratch in a fast-moving, mission-driven biotech environment.
Requirements:
- Bachelor's degree in Life Sciences, Engineering, Chemistry, or related field
- 6–8 years of quality systems or GxP compliance experience in cell and gene therapy (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 Good Documentation Practices (GDocP) principles
- Experience conducting internal and/or supplier audits in a regulated GxP environment; familiarity with ISO 9001, ISO 13485, 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
Preferred Qualifications:
- 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
