Kaleo Software

Director, Quality Systems – Compliance

Kaleo Software

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Lead

About the role

  • 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)

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
  • 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).
Benefits
  • Health insurance
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality systems executionregulatory compliancerisk-based thinkingquality metricsCAPAdocument controldata integrityquality system improvementsaudit performancetrend analysis
Soft Skills
leadershipcommunication skillsanalytical mindsetexecution-focusedaccountabilityprofessionalismperformance managementcoachingproblem-solvingmulti-priority management
Certifications
Bachelor’s degree in life sciencesadvanced degree (preferred)