Director, Quality Compliance
Skills
- Deep knowledge of GxP regulations (GMP, GDP, GLP, GCP)
- Experience leading regulatory inspections (FDA, EMA, MHRA etc.)
- QMS development and oversight
- Audit and third-party qualification expertise
- Risk management and compliance escalation handling
- Cross-functional collaboration and stakeholder influence
- Strong written and verbal communication
Responsibilities
- Lead and oversee the quality compliance function for commercial and clinical programs.
- Manage audit programs including self-inspections, R&D audits, and third-party audits and requalification.
- Execute on critical compliance escalations, risk events, recalls, and complaint handling.
- Maintain and evolve QMS elements: document control, record retention, training, and compliance processes.
- Ensure global inspection readiness and support partner inspection activities.
- Develop, implement, and maintain policies and procedures aligned with FDA, EMA, ICH and other regulations.
- Serve on Quality Leadership Team and influence strategy, governance, and resource planning.
Education
- Bachelor's degree in life sciences, engineering, or related field required
- Advanced degree (MS/PhD) preferred
Benefits
- Hybrid work model (onsite ~3 days/week)
- Mission-driven, collaborative company culture emphasizing diversity and inclusion
- Full-time employment with standard employee benefits (health and related benefits)
- Opportunity to shape and scale global quality compliance programs
Average salary estimate
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