QMS Compliance Manager - IVD cGMP

The QMS Compliance Manager is a hands‑on leader and change agent responsible for building, implementing, and sustaining a compliant, scalable IVD cGMP Quality Management System (QMS) across Cytek facilities. This role develops practical processes, strengthens documentation discipline, and coaches teams to confidently operate within FDA‑ and ISO‑regulated environments. The position partners closely with cross‑functional leaders to drive the transition from non‑GMP to full cGMP operations, ensuring readiness for audits and long‑term regulatory compliance.

To perform this job successfully, an individual must be able to perform essential duties and responsibilities satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Build, implement, and maintain a compliant IVD cGMP QMS aligned with 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62304, IEC 62366, and applicable domestic and international regulatory requirements.
• Develop, revise, and manage SOPs, work instructions, forms, and process maps.
• Lead gap assessments and execute remediation plans across functional areas.
• Drive continuous improvement through audits, CAPA management, and risk assessments.
• Track and report key quality metrics (e.g., CAPA, NCs, audit findings) to leadership.

• Conduct internal audits and walkthroughs to verify GMP compliance.
• Support and participate in external audits (FDA, Notified Bodies), including front‑room and back‑room activities.
• Monitor regulatory changes and ensure QMS updates are implemented.

• Serve as a change agent guiding the organization through the shift to a fully compliant cGMP environment.
• Partner with cross‑functional leaders to define process ownership, close gaps, and ensure operational readiness.
• Influence and motivate teams to adopt compliant, sustainable practices while enabling business execution.

• Develop and deliver targeted QMS and cGMP training for Manufacturing, R&D, Quality, Supply Chain, and support teams.
• Coach personnel at all levels on documentation discipline, QMS expectations, and audit readiness.
• Foster a "quality-first" mindset through hands‑on mentorship and visible leadership.

• Oversee key Quality System elements:
  Document Control, Change Control, Training Records, Nonconformance Management, CAPA, Supplier Quality, Internal Audits
• Ensure timely investigations, robust root cause analysis, and effective CAPA closure.

• Partner with R&D and Engineering to ensure Design Controls are implemented and maintained per 21 CFR Part 820 Subpart C / QMSR, including Design History File (DHF) structure, design reviews, and verification and validation planning.
• Support 510(k) submission readiness activities, including Technical File compilation, design traceability, and alignment of QMS records to regulatory submission requirements.
• Oversee software lifecycle documentation per IEC 62304 and usability engineering activities per IEC 62366, ensuring alignment between development outputs and QMS records.
• Champion risk management practices per ISO 14971 across the product lifecycle, from design input through post‑market surveillance.

• Bachelor's or Master's in Engineering, Life Sciences, Pharmacy, or related field.
• 8+ years in a GMP‑regulated environment (IVD preferred).
• Proven experience building and implementing QMS processes from the ground up.
• Deep understanding of FDA QSR/QMSR (21 CFR Part 820/Part
  4), ISO 13485, ISO 14971, IEC 62304, IEC 62366, cGMP, and IVD regulatory expectations.
• Demonstrated success leading organizations through cGMP transitions.
• Demonstrated experience leading RUO-to-IVD organizational and cultural transition‑in‑cluding managing cross‑functional resistance, establishing design control and documentation discipline in R&D‑driven environments, and aligning multi‑functional teams to cGMP expectations. (required)
• Working knowledge…