Kaléo is hiring a Director, Quality Systems & Compliance

Requirements

• Strong working knowledge of applicable FDA regulations and global quality standards, including 21 CFR Parts 210, 211, 11, and 820/QMSR, as well as ISO 13485, 14971, and related standards, with demonstrated experience applying these requirements within virtual manufacturing, contract manufacturing, and sterile injectable environments.
• Ability to apply risk-based thinking and sound judgement within established direction and escalation pathways.
• Demonstrated capability to manage multiple priorities while maintaining quality system effectiveness.
• Clear, professional communication skills suitable for regulatory, auditor, and customer interactions.
• Analytical mindset with the ability to identify trends, signals, and system-level issues.
• Execution-focused leadership style with emphasis on follow-through, accountability and results.
• Bachelor’s degree in a life sciences discipline required; advanced degree preferred.
• Progressive experience in Quality Assurance within pharmaceutical, medical device, and/or combination product environments, including responsibility for quality systems execution and external audits.
• Demonstrated experience leading or supporting regulatory inspections and external audits
• Prior people leadership experience with accountability for performance and development.
• Working knowledge of electronic QMS platforms and quality system reporting tools (for example: such as MasterControl, Veeva, TrackWise, Documentum, JReports, or equivalent systems/tools)

Nice to Have

• Experience operating within customer-facing or multi-standard quality environments preferred.

Work Arrangement

Hybrid

Additional Information

• Ability to travel up to 25 - 40% overnight (depending on location).