Quality Compliance Lead

Your tasks

About the role The Compliance Lead is responsible for leading the site Quality Compliance function and ensuring a sustainable state of GMP inspection readiness across all quality systems and GMP operations. The role serves as the primary site authority for compliance oversight, regulatory intelligence, inspection management, self-inspection programs, and compliance risk management. The Compliance Lead drives a proactive quality and compliance culture through effective governance, trend analysis, continuous improvement initiatives, and cross-functional partnership to ensure compliance with applicable regulatory requirements and company standards.

• Lead and manage the full lifecycle of client and regulatory inspections/audits, including pre-inspection readiness planning, on-site inspection hosting and coordination, and post-inspection activities including observation triage, CAPA strategy development, formal response drafting, submission, and closure tracking
• Act as the primary site focal point for client and regulatory inspections, ensuring consistent, compliant, and confident representation of the site Quality System and operations
• Own and lead the site Self-Inspection Program, including establishing and maintaining a compliant, risk-based self-inspection strategy, developing annual self-inspection plans, and ensuring timely issuance of self-inspection reports and effective follow-up, tracking, and closure of CAPAs
• Perform systematic trend analysis of audit, self-inspection, and regulatory observations, identifying recurring issues, compliance risks, and continuous improvement opportunities within the QMS, and provide actionable recommendations to functional owners and senior management
• Drive continuous improvement of audit, inspection, and self-inspection processes, including optimization of inspection readiness and audit execution models, enhancement of audit and inspection tools, templates, and tracking systems
• Monitor global and local regulatory requirements and inspection trends (e.g., FDA, EMA, HSA, ICH, PIC/S), perform regulatory intelligence monitoring and impact assessments, and lead site-level gap assessments against new or evolving regulatory expectations
• Lead and track site-level regulatory commitments and authority observations, ensuring clear ownership and prioritization, timely and effective remediation, and implementation of lessons learned to sustain inspection readiness
• Provide compliance guidance and advisory support to site leadership and cross-functional teams on audit readiness, self-inspection findings, regulatory risks, and Quality System enhancements

Requirements

• Bachelor's degree or above in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related scientific discipline
• 10-15 years of experience in QA Compliance, Quality Systems, or Regulatory Compliance within pharmaceutical, biotech, or CRDMO environments
• Proven experience hosting and managing regulatory inspections (e.g. FDA, EMA, HSA, PIC/S) and client audits
• Demonstrated experience as owner or lead of site self-inspection programs
• Hands-on experience managing CAPAs, audit responses, and regulatory commitments
• Strong working knowledge of GMP regulations and guidelines including FDA 21 CFR Parts 210/211, EU GMP, PIC/S, ICH Q7/Q9/Q10
• Solid understanding of Quality Management Systems (QMS), inspection readiness, and risk-based compliance approaches
• Strong inspection hosting, communication, and stakeholder-management skills, with the ability to interact confidently with regulators and clients
• Ability to analyze inspection and audit observations, identify systemic issues, and propose practical, sustainable improvements
• Excellent technical writing skills, particularly for audit reports, inspection responses, and CAPA documentation