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.
