Sr. Manager – Training Operations

Sr. Manager – Training Operations

Requirements

• Bachelor’s degree in a relevant field such as Biotechnology, Engineering, or Education; advanced degree preferred.
• Minimum of 6-10 years of experience in training and development, with at least 3 years of people leadership within the biotechnology or pharmaceutical industry.
• Strong understanding of cell therapy manufacturing preferred; cGMP regulations, and compliance requirements (FDA, EMA, GxP) required.
• Experience designing and implementing training programs in a complex technical pharma or biotech environment.
• Proficiency in Learning Management Systems (LMS) and digital training tools.
• Exceptional project management skills with the ability to manage multiple priorities.
• Strong communication and collaboration skills to work cross-functionally.
• Analytical mindset to assess training effectiveness and drive improvements.
• Detail-oriented, with a strong commitment to quality, compliance, and safety.
• Ability to multitask and prioritize effectively in a fast-paced environment.
• Strong problem-solving skills and a proactive mindset for process improvements.
• Ability to work in cleanroom environments and follow GMP cleanroom protocols.
• Comfortable working across various shifts when necessary.
• Occasionally required to ascend/descend stairs, stand, walk, or work at a computer for extended hours.

Responsibilities

• Develop and implement comprehensive, role-based training curricula tailored to Orca Bio’s cell therapy manufacturing.
• Ensure training programs comply with GMP, FDA, EMA, and other regulatory requirements.
• Oversee the development of hands-on workshops, e-learning modules, SOPs, and regulatory training content.
• Collaborate with Subject Matter Experts (SMEs) to ensure training materials are accurate, relevant, and up to date.
• Create and maintain training assessments and certification programs to track competencies and ensure compliance.
• Drive efficiencies to improve the quality of training programs, reduce costs, optimize scalability, and enhance new employee onboarding.
• Oversee the planning and execution of training schedules, ensuring timely and effective delivery.
• Manage training logistics, including scheduling, resource allocation, and trainer coordination.
• Maintain detailed training records in compliance with regulatory standards.
• Ensure training programs support audits and inspections, addressing compliance gaps proactively.
• Monitor training KPIs to evaluate program effectiveness and identify areas for improvement.
• Lead and develop a high-performing training team.
• Foster a culture of continuous learning and operational excellence.
• Stay up to date with industry best practices and emerging trends to refine training strategies.
• Identify opportunities to enhance training methodologies, incorporating blended learning solutions.
• Build relationships with key external partners to build and enhance training pipelines.

Preferred Qualifications

• Strong understanding of cell therapy manufacturing preferred.
• Certification in training and development (e.g., CPLP, CPTM) is a plus.