Associate Director, Compliance - Remote

Overview

The Associate Director, Compliance will lead the development, implementation and management of external and internal GxP (GLP, GCP and GMP) audits. This key position is responsible for all aspects of the audit lifecycle from development of Jade’s risk-based annual audit plan to monitoring and presentation of the performance and maturity of the audit program.

In Short

• Implement and deliver a risk-based and data-driven strategic audit plan.
• Manage all aspects of the audit lifecycle including scheduling, planning, execution, and report issuance.
• Work with cross-functional departments to gather information prior to audits.
• Communicate with suppliers to schedule audits and provide outcomes.
• Ensure CAPA(s) address compliance concerns identified during audits.
• Provide oversight to contractor auditors.
• Develop, implement, and maintain systems for auditing processes.
• Gather and report GxP audit performance measures.

Requirements

• 13+ years of relevant experience in the pharmaceutical industry.
• Advanced degree in a relevant field preferred.
• Background in Biologics Operations.
• Expert level experience in audits.
• Excellent verbal, written, and interpersonal skills.
• Thorough knowledge of compliance requirements.
• Knowledge of domestic and international regulations.
• Experience in leading investigations and root cause analysis preferred.
• Excellent analytical and problem-solving skills preferred.
• Strong leadership and project management abilities preferred.

Benefits

• Fully remote role with up to 20% travel.
• Competitive salary range.
• Opportunity to lead compliance initiatives.
• Engagement in the pharmaceutical industry.