CAPA Manager (contract)

We are seeking a CAPA & Training Compliance Manager to lead and support Corrective and Preventive Action (CAPA) initiatives and training program oversight across manufacturing technical operations and cross-functional teams. This role is ideal for a detail-oriented professional with a strong technical background, deep understanding of GMPs, and experience navigating the drug development lifecycle from early-stage through commercialization.

Key Responsibilities

• Oversee training structure, curricula, and assignment for technical operations and supporting functions
• Communicate CAPA objectives, mitigation plans, and progress updates to internal stakeholders
• Track and monitor CAPA milestones, ensuring timely completion and documentation
• Organize and maintain team communications including meeting agendas, minutes, and action items
• Develop and implement project management tools and templates to support CAPA and training activities
• Ensure all activities are performed in accordance with SOPs and applicable GxP requirements
• Analyze CAPA and training trends and generate compliance metrics for leadership reporting
• Support continuous improvement initiatives and risk mitigation strategies across quality systems

• Bachelor’s degree in Engineering, Life Sciences, or related field
• Minimum of 8 years of experience in the biopharmaceutical industry
• Strong working knowledge of GMPs, biotechnology operations, and the drug development lifecycle
• Experience with Learning Management Systems (LMS) and training program administration
• Familiarity with cell and gene therapy methodologies is a plus
• Solid understanding of risk management principles and CAPA execution best practices
• Expertise in Microsoft Office Suite (Project, PowerPoint, SharePoint, Word, Excel, Outlook)
• Experience with project management tools such as Smartsheet or Power BI is a plus
• Excellent written and verbal communication skills, including presentation and facilitation
• Strong analytical and problem-solving skills with the ability to balance detail and strategy
• Knowledge of regulatory requirements including FDA, 21 CFR Part 211, EU GMP, and ICH Q10

• Contract position possible extension