Director, Quality Compliance

Role Summary

Director, Quality Compliance responsible for FDA and global inspection readiness, internal audits, health authority reporting, and leading a high-performing compliance team to ensure site cGMP compliance and continuous improvement of quality systems.

Responsibilities

• Lead FDA and Health Authority inspection readiness and responses; coordinate mock inspections, on-floor support, and regulatory communications.
• Build and maintain a Permanent Inspection Readiness (PIR) and internal audit program to detect gaps and monitor CAPA effectiveness.
• Track and interpret changes in regulations and industry standards to ensure proactive awareness and PIR at the site.
• Lead root-cause analysis and develop prioritized, measurable corrective and preventive actions; verify effectiveness with clear KPIs.
• Manage, coach, and grow a team of compliance professionals and internal auditors; set expectations and succession plans.
• Provide expertise in developing strategies for inspection readiness including collaborating with Regulatory for submissions for new product launches.
• Oversee Health Authority reporting (BPDRs, DPRs, FARs), market action events, and complaint assessment and reporting decisions.
• Work with responsible teams to author and submit required health authority notifications and follow-up action.
• Partner cross-functionally (Operations, Regulatory, QC, R&D, Supply Chain) and with external suppliers to drive compliance.
• Drive simplification and continuous improvement of quality systems and supplier compliance monitoring.

Qualifications

• BA/BS and 10+ years leading quality audit/inspection strategies in large-molecule biologics or vaccines with strong FDA experience.
• Deep knowledge of cGMP, FDA inspection expectations, and relevant regulations (e.g., 21 CFR Part 11, Annex 11).
• Proven inspection management and PIR experience; experienced in authoring regulatory submissions and responses.
• Strong strategic thinking, analytical problem-solving, and CAPA management skills.
• Demonstrated people leadership in a matrix organization: hiring, coaching, performance management, and team development.
• Excellent communication, technical writing, project management, and stakeholder influence skills.

Skills

• Audit Inspections, Change Management, Coaching, FDA Inspections, FDA Regulations, Interpersonal Relationships, Leadership, Management Process, People Leadership, Quality Auditing, Quality Compliance, Regulatory Compliance, Risk Management, Strategic Thinking, Team Development