Sr. Associate II, Compliance

Role: Senior Associate II, Compliance, responsible for ensuring the RTP Drug Substance Manufacturing site maintains regulatory compliance and inspection readiness. Responsibilities include leading inspection management, data integrity oversight, risk management, and driving continuous improvement across quality systems. The role involves preparing for regulatory audits, coordinating responses, and supporting global quality initiatives, with a focus on data-driven metrics and quality governance. Requirements: Bachelor's in a scientific or technical field, minimum 5 years in Quality Assurance within pharmaceutical or biotech manufacturing, strong knowledge of cGMP, global regulatory standards (FDA, EMA), and experience with inspection management and quality systems like Veeva and TrackWise. Preferred skills include prior compliance-focused roles, expertise in data integrity principles, and experience supporting global quality projects. High-Value: Focus on pharmaceutical manufacturing compliance, inspection readiness, data integrity, and quality systems in a biotech manufacturing environment. The position reports to site leadership, involves cross-functional collaboration, and emphasizes continuous improvement. Work setup details and travel expectations are not specified.