About the job

Purpose

To lead the QA Compliance function, ensuring the site maintains a state of inspection readiness and complies with all applicable regulatory requirements. This role oversees audit management, data integrity programs, quality risk management, pharmacovigilance quality assurance, and the internal self-inspection program.

Responsibilities

• Lead and develop the QA Compliance team to ensure high performance and engagement.
• Allocate resources and prioritize compliance activities to meet business and regulatory objectives.
• Maintain a state of readiness for regulatory inspections and customer audits.
• Plan, coordinate, and manage internal audits and external inspections, including preparation, hosting, and follow-up.
• Ensure timely closure of audit findings and CAPAs.
• Oversee implementation and monitoring of data integrity programs across all systems and processes.
• Ensure compliance with ALCOA+ principles and regulatory expectations for electronic and paper records.
• Lead the site's quality risk management program, ensuring risk assessments are performed and documented appropriately.
• Provide guidance on risk-based decision-making and mitigation strategies.
• Ensure compliance with pharmacovigilance requirements and support audits related to PV activities.
• Collaborate with relevant stakeholders to maintain PV quality systems.
• Manage the site's self-inspection program, including scheduling, execution, and reporting.
• Drive continuous improvement based on findings and trends.
• Identify opportunities to enhance compliance processes and implement best practices.
• Monitor regulatory changes and update compliance programs accordingly.

Requirements

• Degree in Quality Assurance, Pharmaceutical Science, Life Sciences, or related discipline.
• 5+ years in a QA compliance role within a GMP-regulated environment, with at least 2 years in a leadership position.
• Experience in audit management, data integrity, and risk management.
• Strong knowledge of GMP and regulatory requirements.
• Excellent organizational and leadership skills.
• Effective communication and stakeholder management.
• Ability to motivate and guide a team toward achieving compliance objectives.
• Commitment to maintaining high standards of regulatory compliance.
• Skilled in identifying and mitigating compliance risks.
• Ensures accuracy and completeness in documentation and processes.
• Works effectively across departments and with external stakeholders.