QMS Compliance Manager - IVD cGMP

At Cytek Biosciences , we're transforming the future of flow cytometry. As a global leader in spectral technology, our advanced platforms enable deeper scientific discovery, empowering researchers in academic, clinical, and biopharma labs to accelerate their breakthroughs with unmatched precision and efficiency.

We're growing fast-and we're looking for passionate, driven individuals to grow with us. If you're ready to make an impact in a cutting-edge biotech company, this is your opportunity.

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

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.

Quality System Development & Oversight

• 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 Enablement

• 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. (required)
• Working knowledge of Design Controls per 21 CFR Part 820 Subpart C / QMSR, including DHF structure, design verification and validation planning, risk management integration, and 510(k) submission readiness. (preferred)
• Familiarity with GAMP 5 principles and computer/software system validation per 21 CFR Part 11 and applicable IEC standards. (preferred)
• Experience with multi-site QMS harmonization across geographically distributed or international facilities. (preferred)
• Strong analytical, communication, training, and facilitation skills.
• Hands-on, execution-focused mindset; comfortable writing SOPs, running workshops, coaching teams.
• Experience supporting front-room/back-room activities during FDA or Notified Body audits.

ADDITIONAL SKILLS AND 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.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Prolongedperiodssitting at a desk and working on a computer.

Cytek is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, sexual orientation,national origin, genetic information, disability status, veteran status, or any other characteristic protected by law.