Associate Director, GVP/GCP Quality Assurance Auditor

Organon

Responsibilities

• Schedule and conduct assigned GVP/GCP audits in accordance with the global audit plan ensuring compliance with local and international guidelines and regulations.

• Prepare audit reports and manage follow-up activities within established timelines.

• Maintain broad-based expertise in Organon Policies, Procedures and Guidelines, local and global regulatory requirements, etc., pertinent to GCP and GVP. Maintain awareness of evolving industry and regulatory trends/regulations.

• Obtain and maintain cutting-edge knowledge, and application, for various Quality auditing topics.

• Generate and present comprehensive presentations/summary of audit issues for effective communication to all levels, as needed.

• Leads initiatives / drive results in various projects, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet company and regulatory expectations.

• Supports the implementation and maintenance of the GVP/GCP risk-based strategy, including assistance in the development of the annual audit plan and maintenance of the audit tool.

• Reviews and provides input into the quality sections of the Pharmacovigilance System Master File (PSMF)

• Supports regulatory inspections and external audits, when required.

• Train and mentor junior team members.

Primary skills include but are not limited to:

Collaboration and Partnering: Demonstrates ability to work in partnership with others within the Company and external partners to accomplish quality goals; possesses advanced leadership skills.

Communication Skills: Strong verbal skills and experienced effective writing skills.

Project Management: Demonstrates ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.

Decision Making: Demonstrates skills to utilize knowledge, networks, and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.

Business Operations/Knowledge of Field: Demonstrates knowledge of regulations. Regulatory and business trends and applies this knowledge to optimize daily activities and ensure the functional areas within Research and Development are compliant with regulations and appropriate procedures.