Manager, Clinical QA Program Lead

Audit Responsibilities

• Audit strategy:
  Drives and delivers audit strategies and capabilities for applicable therapeutic program level(s), Clinical System, Clinical Supplier, or Local Operating Company audits.
• Fosters the partnership between audit strategy and execution teams and enhance the value of Clinical audit programs.
• Monitors audit outcome trends and identifies collaboration opportunities with stakeholders to resolve compliance related matters.
• Conducts GCP audits & supports GxP Audits as applicable (expected up to 50% time).
• Develops tactical and operational audit plans to implement and deliver domain-specific audit strategies.
• Independently leads and manages domain-specific compliance audit programs as laid down in a comprehensive audit schedule.
• Guides auditors in the scope definition, planning, conduct and reporting of audits.
• Prepares and reviews audit summary reports to share/escalate significant information with senior leaders.

• A minimum of a bachelor’s or equivalent University degree is required.
• Requires at least 5 years’ experience in an applicable compliance field and/or equivalent time and experience in a related R&D area (GxP-regulated discipline).
• Experienced in conducting GCP audits.
• Experienced in developing audit strategies and capabilities for applicable therapeutic program level(s), GCP System, and/or GCP Supplier audits.
• Must be able to work onsite 3 days/week at JNJ location.

Demonstrates expertise in developing and executing audit strategies within GxP-regulated environments, with a strong focus on GCP audits and compliance. Capable of leading audit programs, preparing comprehensive reports, and fostering collaboration among stakeholders.