About the Role
Lead the strategy, development, and continuous improvement of the company's quality management systems to support clinical-stage programs and future commercialization efforts.
Responsibilities
- Direct the design and implementation of quality systems aligned with current and future operational needs.
- Ensure compliance with FDA, EMA, and other global regulatory requirements.
- Oversee internal and external audits, driving corrective actions and process enhancements.
- Manage documentation systems including policies, SOPs, and quality records.
- Lead quality risk assessments across manufacturing, testing, and clinical operations.
- Collaborate with cross-functional teams to integrate quality into project timelines.
- Support regulatory submissions by ensuring quality systems meet agency expectations.
- Develop and deliver quality training programs for internal staff and partners.
- Monitor key performance indicators and metrics to assess system effectiveness.
- Drive continuous improvement initiatives using data-driven methodologies.
- Oversee vendor quality agreements and ensure third-party compliance.
- Lead investigations into deviations, CAPAs, and non-conformances.
- Ensure change control processes are robust and consistently applied.
- Maintain product lifecycle quality oversight from development through manufacturing.
- Support facility readiness for regulatory inspections and audits.
- Establish quality oversight for contract manufacturing and testing organizations.
- Ensure data integrity standards are upheld across all quality systems.
- Lead preparation for pre-approval and routine regulatory inspections.
- Work closely with clinical operations to ensure trial compliance with GCP.
- Support product release and stability testing in alignment with GMP standards.
- Evaluate emerging regulations and adapt systems proactively.
- Foster a culture of quality and compliance across the organization.
- Manage quality documentation workflows and electronic system validation.
- Coordinate responses to regulatory observations or 483s.
- Ensure supplier qualification and ongoing performance monitoring.
Compensation
Competitive salary and benefits package offered.
Work Arrangement
Hybrid work model with both remote and on-site requirements.
Team
Part of the Quality organization reporting to senior leadership.
Why This Role Matters
This position plays a critical role in ensuring product safety, regulatory compliance, and patient trust as the company advances its pipeline toward commercialization.
Growth Opportunity
The hire will shape the future of the quality function, contributing directly to organizational scalability and long-term success.
Collaboration Style
Success requires close partnership with R&D, manufacturing, clinical, and regulatory teams to embed quality into every process.
Technology & Tools
The role utilizes electronic quality management systems, audit tools, and data analytics platforms to monitor and improve performance.
Regulatory Environment
Work occurs under strict regulatory oversight with expectations for inspection readiness at all times.
Leadership Expectations
The individual must lead by example, promoting accountability, transparency, and continuous learning within the quality culture.
Work Environment
Fast-moving, mission-driven setting with emphasis on precision, compliance, and patient impact.
Onboarding Focus
Initial priorities include assessing current quality systems, identifying gaps, and establishing improvement roadmaps.
Strategic Impact
The role contributes to long-range planning by aligning quality systems with corporate milestones and regulatory timelines.
Performance Metrics
Success will be measured by audit results, inspection outcomes, system compliance, and team development.
Sponsorship available for qualified candidates.
