Director, Quality Systems & Compliance

This is a remote opportunity with occasional travel, estimated at 25%-40%.

Kaléo is a global leader in drug‑delivery device technology and auto‑injector innovation, providing millions of patients, government partners, and emergency responders with security and peace of mind.

The Director, Quality Systems and Compliance, is accountable for the performance and sustained effectiveness of the Quality Management System (QMS) in support of patient safety, regulatory compliance, inspection readiness, and customer confidence across the product lifecycle. This role ensures quality systems are effective, reliable, and aligned with organizational objectives across development, manufacturing, and commercial activities.

The Director serves as a senior quality leader and system owner, operating within established quality governance and direction. The role focuses on translating defined expectations into practical systems, processes, and controls, while providing strong external-facing leadership during regulatory, customer, and notified body audits.

The Director, Quality Systems and Compliance, strengthens the Quality Assurance function by ensuring the QMS performs reliably under regulatory scrutiny, customer audit expectations, and ongoing operational demands. This role supports both internal product oversight and customer programs by maintaining quality systems that are auditable, inspection-ready, and aligned with regulatory and contractual requirements critical to patient safety and business continuity.

As Director, Quality Systems and Compliance you will:

Audit & Inspection Leadership

• Lead regulatory inspections, notified body audits, customer audits, and third-party assessments, including preparation, on-site execution, response coordination, and remediation activities through closure.
• Serve as the quality representative for external audit engagements, including direct interaction with regulators, customers, notified bodies, and auditors.

Quality Systems Execution & Improvement

• Execute and improve assigned quality systems to ensure sustained inspection readiness, regulatory compliance, and effective audit performance.
• Design, implement, and optimize quality system processes to sustain inspection readiness and regulatory compliance.
• Apply regulatory requirements, industry standards, and customer expectations to develop practical, risk-based quality system solutions.
• Identify quality system gaps, risks, and improvement opportunities through audit outcomes, trend analysis, and quality data review.
• Design and implement quality system improvements informed by regulatory intelligence, audit feedback, and operational experience.

Quality Integration & Performance Monitoring

• Support quality integration for new product introductions, platform deployments, technology transfers, and customer onboarding activities.
• Partner with Development, Operations, Supply Chain, Regulatory Affairs, and Commercial teams to implement quality system requirements and improvements,
• Establish and report quality metrics, trends, and management inputs to leadership.
• Lead and develop quality systems staff though clear expectations, coaching, and performance management.
• Provide oversight of electronic GxP quality systems, ensuring compliance and effective coordination with system administrators responsible for day-to-day configuration support.

Leadership & Management

• Lead, manage, and hold accountable assigned Quality Systems personnel, including setting performance expectations, providing ongoing feedback, and conducting performance evaluations in alignment with organizational policies.
• Identify capability gaps and support hiring, onboarding, and development activities to ensure the team can effectively execute quality system responsibilities.

QMS Oversight

The Director executes and oversees core elements of the QMS, with direct ownership of key activities, coordination of cross-functional inputs, and accountability for overall system performance, including but not limited to:

• Quality Risk & Change Management (Change Management, CAPA, Investigations)
• Product & Patient Impact Systems (Complaints, Field Alerts, Product Quality Investigations, APQR)
• Documentation & Data Integrity (Document & Record Control, GxP Computerized System oversight)
• Supplier & External Quality Oversight (Supplier Quality Management, Internal, Supplier, and Customer Audits)
• Inspection Readiness & Regulatory Compliance Intelligence (Regulatory and Notified Body Readiness, Inspection Intelligence)
• Quality Performance Monitoring (Quality Metrics, Trending, and Reporting)

To be considered for the position, you must have:

• 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.

Additional qualifications:

• 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
• Experience operating within customer-facing or multi-standard quality environments preferred.
• 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)
• Ability to travel up to 25 - 40% overnight (depending on location).