BioPharma Consulting JAD Group
2 days ago Be among the first 25 applicants
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.
You can get further details about the nature of this opening, and what is expected from applicants, by reading the below.
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 Seniority level
Seniority levelMid-Senior level Employment type
Employment typeContract Job function
Job functionManagement IndustriesIT Services and IT Consulting Referrals increase your chances of interviewing at BioPharma Consulting JAD Group by 2x Sign in to set job alerts for “Contract Manager” roles. Boston, MA $56,000.00-$72,000.00 6 days ago Somerville, MA $96,500.00-$144,800.00 15 hours ago Manager, Contracts & Transactions, Operational Excellence Cambridge, MA $111,800.00-$175,670.00 1 week ago Tewksbury, MA $101,000.00-$203,000.00 11 hours ago Manager, Contracts & Transactions, Operational Excellence Cambridge, MA $111,800.00-$175,670.00 1 week ago Tewksbury, MA $124,000.00-$250,000.00 2 weeks ago Director of Contract Compliance and Procurement Cambridge, MA $132,167.00-$163,266.00 4 days ago Contract Office Manager/HR Generalist (Must Have Prior HR Experience) Marlborough, MA $72,800.00-$138,300.00 2 weeks ago Manager of International Claims - Commercial Marlborough, MA $113,600.00-$147,700.00 1 week ago Boston, MA $86,000.00-$100,000.00 3 weeks ago Software Contract Renewals Manager - Remote Available Framingham, MA $101,500.00-$131,900.00 3 weeks ago Manager, Commercial Negotiations & Projects (IC Role) Boston, MA $130,000.00-$170,000.00 4 weeks ago Senior Manager/Associate Director, Records Management Wellesley, MA $119,400.00-$179,100.00 3 weeks ago Boston, MA $104,383.00-$117,431.00 5 months ago Pre-Construction Manager - Amazon AIR, NA Design and Construction, Amazon AIR Boston, MA $81,200.00-$181,600.00 4 days ago QRM - Contract Obligations Support Specialist (Manager) - National_Office We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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You can get further details about the nature of this opening, and what is expected from applicants, by reading the below.
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 Seniority level
Seniority levelMid-Senior level Employment type
Employment typeContract Job function
Job functionManagement IndustriesIT Services and IT Consulting Referrals increase your chances of interviewing at BioPharma Consulting JAD Group by 2x Sign in to set job alerts for “Contract Manager” roles. Boston, MA $56,000.00-$72,000.00 6 days ago Somerville, MA $96,500.00-$144,800.00 15 hours ago Manager, Contracts & Transactions, Operational Excellence Cambridge, MA $111,800.00-$175,670.00 1 week ago Tewksbury, MA $101,000.00-$203,000.00 11 hours ago Manager, Contracts & Transactions, Operational Excellence Cambridge, MA $111,800.00-$175,670.00 1 week ago Tewksbury, MA $124,000.00-$250,000.00 2 weeks ago Director of Contract Compliance and Procurement Cambridge, MA $132,167.00-$163,266.00 4 days ago Contract Office Manager/HR Generalist (Must Have Prior HR Experience) Marlborough, MA $72,800.00-$138,300.00 2 weeks ago Manager of International Claims - Commercial Marlborough, MA $113,600.00-$147,700.00 1 week ago Boston, MA $86,000.00-$100,000.00 3 weeks ago Software Contract Renewals Manager - Remote Available Framingham, MA $101,500.00-$131,900.00 3 weeks ago Manager, Commercial Negotiations & Projects (IC Role) Boston, MA $130,000.00-$170,000.00 4 weeks ago Senior Manager/Associate Director, Records Management Wellesley, MA $119,400.00-$179,100.00 3 weeks ago Boston, MA $104,383.00-$117,431.00 5 months ago Pre-Construction Manager - Amazon AIR, NA Design and Construction, Amazon AIR Boston, MA $81,200.00-$181,600.00 4 days ago QRM - Contract Obligations Support Specialist (Manager) - National_Office We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr