Head of Quality and Regulatory

Head of Quality and Regulatory

Cytovale Inc. South San Francisco CA

Reports to: Chief Operating Officer
Level: Senior Director / Vice President commensurate with experience
Function: Quality and Regulatory Compliance
Location: Bay area onsite role

About Cytovale

Cytovale is a medical diagnostics company focused on providing a faster more insightful way to diagnose fast-moving and immune-mediated diseases. Cytovales IntelliSep test is the first and only stand-alone sepsis detection assay to quickly and accurately analyze white blood cell structure to stratify a patients risk of sepsis. The test simply and clearly shows risk of sepsis using a biomechanical evaluation of white blood cells from a standard blood draw generating results in less than 10 minutes. For more information please visit .

Job Description

The Head of Quality and Regulatory owns Cytovales Quality Management System and serves as the companys designated Management Representative. This leader is accountable for the effectiveness and compliance of the QMS under FDA QMSR (21 CFR Part 820) ISO 13485 ISO 14971 and applicable IEC standards and for the quality engineering capability that supports design change process validation and on-market product improvement for the IntelliSep system and its consumables.
The role is quality-first with a strong regulatory partnership. Working alongside the Senior Director of Regulatory Affairs the Head of Quality and Regulatory shapes an 18- to 24-month regulatory roadmap spanning letters to file Special and Traditional 510(k)s and Predetermined Change Control Plans (PCCPs) so that product and reliability improvements reach customers predictably and compliantly. The position leads all internal and external audits third-party registrations and agency inspections and is expected to make the organization both more compliant and more nimble.

Key Responsibilities

Quality Strategy and Leadership

• Define and execute an enterprise Quality strategy that supports regulatory obligations operational objectives and long-term growth; establish annual quality objectives and the KPIs used to report progress to executive leadership.
• Lead a multidisciplinary Quality organization spanning Quality Assurance Quality Engineering Design Quality Quality Systems Process Validation Incoming Inspection and the audit program.
• Set the strategy for quality infrastructure including eQMS evolution and the application of AI and analytics to quality processes.

Quality Management System and Compliance

• Serve as Management Representative; own the effectiveness of the QMS and its core processes including CAPA nonconformance and deviation management complaint handling change control document control training and management review.
• Drive process improvements that allow the organization to move quickly while maintaining full FDA ISO and QMSR compliance with documentation that is cohesive consistent and built on continuous-improvement principles.
• Establish and sustain a disciplined operating rhythm for internal audits annual post-market reviews and periodic management reviews.
• Maintain a proactive state of inspection readiness and lead the organization through FDA inspections Notified Body audits and third-party registration activities.

Design Quality Change Management and Regulatory Roadmap

• Direct design quality assurance across product development and design-change programs allocating resources managing budgets and embedding quality engineers in project teams to ensure efficient compliant execution.
• Partner with the Senior Director of Regulatory Affairs to develop and maintain a forward-looking 18- to 24-month regulatory roadmap covering letters to file Special and Traditional 510(k)s and PCCPs that enable feature and reliability improvements.
• Provide subject matter expertise in design of experiments process validation statistical methods software validation test method validation and measurement systems analysis risk management and FMEA and cybersecurity.

Manufacturing Supplier and Product Quality

• Own the Quality Improvement Plans for the IntelliSep instrument and associated consumables and partner with Manufacturing and Engineering on qualification process capability and design-transfer activities.
• Govern manufacturing process changes with appropriate validation and documentation and ensure nonconformances are investigated and closed promptly.
• Direct the supplier quality program in collaboration with Supply Chain and R&D including supplier selection and qualification audits performance monitoring and supplier corrective actions.

Post-Market Surveillance and Continuous Improvement

• Own the post-market surveillance process end to end from complaint intake through investigation trending product-improvement ticketing and MDR and vigilance reporting.
• Monitor quality performance through data analysis and trend identification to surface risks early and prioritize improvement initiatives.
• Lead complex investigations and root-cause analyses; strengthen CAPA effectiveness and build organizational capability in structured problem solving.

People and Culture

• Build coach and develop a high-performing team of quality engineers quality professionals and future quality leaders; foster accountability engagement and ownership at every level.
• Champion a company-wide culture of quality through hands-on leadership cross-functional partnership and visible participation in QE and QMS activities.

Minimum Qualifications

• Bachelors degree in engineering discipline.
• 10 years of progressive quality leadership in the medical device or IVD industry with 7 years of experience managing quality teams and organizational performance.
• Demonstrated success leading a QA/RA function at a small- to mid-sized Class II device company with an emphasis on process and on-market product improvement.
• Deep working knowledge of FDA QMSR (21 CFR Part 820) ISO 13485 cGMP and IVD-specific regulatory and quality requirements.
• Track record of leading FDA inspections and Notified Body audits and sustaining inspection readiness.
• Significant experience leading both Quality Assurance and Quality Control organizations including inspection and test method development and validation.
• Applied expertise in risk analysis FMEA Impact/hazard analysis statistical methods and process and software validation.
• Proven ability to lead structured problem solving apply data- and risk-based decision making and drive sustainable corrective actions.
• Experience driving cultural change and building high-functioning cross-functional teams; thoughtful analytical and intellectually curious.

Preferred Qualifications

• MBA or Masters degree in engineering or related field.
• Hands-on experience with eQMS platforms and AI-enabled quality tools.
• Six Sigma Green Belt or Black Belt certification.
• Certified internal auditor (ISO 13485) or comparable ASQ certification (CQA CQE CMQ/OE).

Compensation

Competitive and commensurate with experience.

Required Experience:

Director