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About this Job
Location: Boston, MA (Onsite)
Length: 12+ Month Contract
Please no agencies. Direct employees currently authorized to work in the United States – no sponsorship available
Job Description:
The CAPA and Training Manager is responsible for supporting the MTO (Manufacturing Technical Operations) and cross-functional teams initiating, implementing and closing CAPAs, developing and distributing CAPA and training compliance metrics, reporting on CAPA and training trends, and overseeing training structure and assignment. Candidates should be comfortable adapting to evolving priorities and staying flexible.
Must be detail-driven and have a proven history in meeting deadlines and driving success within the biotech industry. The individual requires a strong technical background, solid working knowledge of GMPs, experience working with LMS, understanding of the drug development pathway through commercialization, and willingness to pivot as priorities change. Knowledge and/or experience with cell / gene therapy methodologies and a strong understanding of risk management will be an asset. Must have excellent communication skills, written and verbal, high attention to detail, and the ability to work effectively in cross-functional, matrixed teams.
Essential Duties and Responsibilities:
- Oversee training structure, curricula and assignment for MTO and cross-functional teams.
- Effectively communicate with internal team members and key stakeholders on the objectives, mitigation plans, and development of meaningful CAPAs.
- Track and monitor key milestones and work with cross functional team members to drive the completion of CAPAs.
- Organize and maintain team communications including meeting agendas, minutes, and follow up task lists.
- Develop and deliver project management tools and templates to manage CAPA and Training team activities.
- Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable
Qualifications:
- Bachelor’s degree in engineering, life sciences or related field.
- A minimum of 8 years of experience in the biopharmaceutical industry.
- Working knowledge of biotechnology, GMPs, and drug development lifecycle.
- Ability to work effectively in cross-functional, matrixed environment, prioritizing and managing multiple tasks simultaneously, integrating cross-functional issues and balancing competing priorities effectively.
- Expertise in Microsoft suite (Project, PowerPoint, SharePoint, Word, Excel, Outlook). Experience with other PM tools a plus (e.g., Smartsheet, Power BI, etc.).
- Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates and issues across all levels of the organization.
- Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective.
- Strong understanding of regulatory requirements (FDA, 21 CFR Part 211, EU GMP, ICH Q10)
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
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4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
Voted ‘Best Staffing Firm to Temp/Contract For’ 8 consecutive years in a row by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.
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