layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Staff Quality Systems & Compliance Engineer at Multiply Labs

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 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.
Compliance & Data Integrity
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.
Audits & Inspection Management
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
Supplier Quality
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.
Management Review & Quality Reporting
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.
Qualifications: 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.
Additional 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.

Staff Quality Systems & Compliance Engineer

Employer job description

The Mission:

The Technology:

The Location:

The Backing:

Responsibilities: Quality Systems

Perks & Benefits: Total Rewards & Life at Multiply Labs

Competitive Compensation:

Salary range of

Premium Health:

Wealth Building:

Parental Support:

True Flexibility:

No Set Hours:

Office Perks:

About this listing