Manager, Clinical QA Program Lead

Responsibilities

• Drives and delivers audit strategies and capabilities for applicable therapeutic program level(s), Clinical System, Clinical Supplier, or Local Operating Company audits, ensuring connectivity and holistic alignment of strategies.
• Fosters the partnership between audit strategy and execution teams and enhances the value of Clinical audit programs through improving the audit report peer review process and the analysis and communications of meaningful audit outcomes.
• Monitors audit outcome trends and identifies pro‑active collaboration opportunities with stakeholders to resolve and address compliance‑related matters and identify opportunities to enhance audit strategy and overall quality and compliance of clinical programs across therapeutic areas.
• Maintains and shares expert‑level GCP knowledge with the ability to provide critical information, advice and guidance on complex quality and compliance issues.
• Leverages data analytics tools to analyze relevant data sources.
• Evaluates and analyzes the data to identify any relevant trends and insights as input for the development of the appropriate audit program.
• Conducts GCP audits and supports GxP audits as applicable (expected up to 50% of time) with a focus on audits relevant to the responsible therapeutic areas.
• Develops tactical and operational audit plans to implement and deliver domain‑specific audit strategies.
• Ensures the relevant standard procedures, audit scopes and audit plans are fully understood and applied in audit activities.
• Independently leads and manages the domain‑specific compliance audit programs as laid down in a comprehensive audit schedule, through planning, conducting and reporting of QA audits of activities, data, internal and external facilities and processes in GxP/non‑regulated areas to assure adherence to company internal standards and policies/requirements, and compliance with applicable (Health Authority) regulatory requirements.
• Guides auditors in the scope definition, planning, conduct and reporting of audits, providing regulatory and process expertise within the applicable therapeutic area program(s).

• 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 expert‑level knowledge in Good Clinical Practice (GCP) and compliance, with a strong ability to develop and implement audit strategies and conduct GCP audits. Leverages data analytics to identify trends and enhance audit quality across therapeutic areas.