CAPA Manager (contract) Job at BioPharma Consulting JAD Group, Boston, MA

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  • BioPharma Consulting JAD Group
  • Boston, MA

Job Description

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

Requirements

  • 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

Benefits

  • Contract position possible extension

Job Tags

Contract work, Work at office,

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