Quality Compliance Lead

Quality Compliance Lead

The Quality Compliance Lead is responsible for ensuring site compliance with FDA regulations, cGMP requirements, corporate standards, and Quality Management System expectations. The role drives inspection readiness, CAPA management, regulatory remediation programs, quality system effectiveness, and cross-functional compliance initiatives while providing leadership with clear visibility of compliance risks and performance. S/he works as a core member of the Quality team to manage site compliance to achieve World Class Quality performance as measured by our core Key Performance Indicators in the DEO Center of Excellence.

• Lead the site's regulatory compliance program and oversee execution of FDA, BRC, Corporate and Internal Quality Commitments to complete and maintain internal and external audits and certifications.

• Manage and track all corrective and preventive actions (CAPAs), ensuring actions are completed on time and sustained through effectiveness verification.

• Coordinate inspection readiness activities, mock inspections, regulatory audits, and responses to regulatory observations.

• Provide independent oversight of deviation investigations, root cause analyses, product impact assessments, and CAPA implementation.

• Ensure consumer complaint investigations are completed accurately, thoroughly, and within established timelines.

• Oversee data integrity programs, including audit trail review, electronic records management, backup controls, and compliance with computerized system requirements.

• Monitor compliance of maintenance, calibration, preventive maintenance, and work order systems affecting GMP equipment and product quality.

• Govern equipment integrity programs, including risk assessments, inspection programs, interim controls, and long-term remediation projects.

• Lead compliance oversight of validation programs, including cleaning validation, process validation, equipment qualification, and revalidation activities.

• Ensure equipment history, maintenance records, and quality documentation are complete, accurate, and audit ready.

• Oversee annual reserve sample inspection programs and ensure compliance with applicable FDA requirements and site procedures.

• Develop, monitor, and report compliance metrics, trends, risks, and regulatory commitments to Site Leadership and Quality Management Review.

• Partner with Quality, Operations, Engineering, Maintenance, R&D, and Supply Chain teams to drive continuous improvement and strengthen quality systems.

• Ensure new and revised procedures are effectively implemented through training, auditing, and ongoing compliance verification.

• Escalate compliance risks, overdue actions, recurring quality issues, and regulatory concerns to senior management when appropriate.

• Management of yearly regulatory testing requirements.

• Manage the site's change management process.

• Participate in the Quality Pillar as a core team member and help in defining relevant KPIs, building scorecards & reports for Quality KPIs, analyzing data and drawing insights to drive Quality improvement using advanced statistical tools (SPC and Capability analysis).

• Ensure good manufacturing practices are always in place; set example and champion Quality initiatives.

• Maintain knowledge of current industry standards and best practices by actively engaging in relevant learning, networking, and professional development opportunities.

• You're a born leader:
You are self-directed, identifying problems and proactively solving using proven problem solving methods.

• You love to win, and have fun doing it:
We have fun while ensuring the customer expectations are met each and every time.

• You're a story teller:
We look at trends to determine best next steps based…