QMS Compliance Manager - IVD cGMP

About the role

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.

Responsibilities

• 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.

Compliance & Audit Management

• 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.

Change Leadership & Organizational Transition

• 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.

Training, Coaching & Cross-Functional

• 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.

Quality Operations & Daily Compliance

• 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.
• Design Control & Product Development Support: 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.

Requirements & Qualifications

• 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—including managing cross-functional resistance, establishing design control and documentation discipline in R&D-driven environments, and aligning multi-functional teams to cGMP expectations.

Additional Skills & Competencies

• Quality certifications preferred (CQA, CMQ/OE, ISO Lead Auditor).
• Strong collaboration skills across R&D, Manufacturing, Quality, and Supply Chain.
• Skilled in structured problem-solving, CAPA, and process improvement.
• Adaptable, persuasive communicator able to gain buy-in at all levels.
• Thrives in fast-paced, scaling environments.
• Familiarity with the QMSR (21 CFR Part 4) transition from legacy QSR; experience aligning QMS infrastructure to support 510(k) or CE marking submissions.
• Experience harmonizing QMS processes across multi-site, multinational operations, including domestic and international manufacturing or R&D facilities.
• Comfort navigating ambiguity in organizational change, particularly in environments where quality ownership boundaries between QA, R&D, and Engineering are still being established.