Job Description

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.

Key responsibilities

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

About you

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