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Senior Manager Training Operations
Orca BioSacramento, United Statesfull_timeVerifiedPosted 21 Mar 2025
About the role
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
The Associate Director, Training Operations will be responsible for the design, implementation, and delivery of learning programs for Orca Bio’s supply chain operations functions. This role is responsible for the strategic planning, development, implementation, and management of the training programs and training compliance for Orca Bio’s cell therapy manufacturing, and related functions. The ideal candidate will bring expertise in training development cycles, instructional design, and compliance-driven training programs while ensuring that all initiatives align with industry regulations and organizational objectives. Responsibilities:
· Training Program Development and Executiono Develop and implement comprehensive, role-based training curricula tailored to Orca Bio’s cell therapy manufacturing.o Ensure training programs comply with GMP, FDA, EMA, and other regulatory requirements.o Oversee the development of hands-on workshops, e-learning modules, SOPs, and regulatory training content.o Collaborate with Subject Matter Experts (SMEs) to ensure training materials are accurate, relevant, and up to date.o Create and maintain training assessments and certification programs to track competencies and ensure compliance.o Drive efficiencies to improve the quality of training programs, reduce costs, optimize scalability, and enhance new employee onboarding.
Training Operations & Compliance
o Oversee the planning and execution of training schedules, ensuring timely and effective delivery.o Manage training logistics, including scheduling, resource allocation, and trainer coordination.o Maintain detailed training records in compliance with regulatory standards.o Ensure training programs support audits and inspections, addressing compliance gaps proactively.o Monitor training KPIs to evaluate program effectiveness and identify areas for improvement. Leadership & Continuous Improvement
o Lead and develop a high-performing training team.o Foster a culture of continuous learning and operational excellence.o Stay up to date with industry best practices and emerging trends to refine training strategies.o Identify opportunities to enhance training methodologies, incorporating blended learning solutions.o Build relationships with key external partners to build and enhance training pipelines Qualifications:
Technical Qualities
o Bachelor's degree in a relevant field such as Biotechnology, Engineering, or Education; advanced degree preferred.o 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. o Strong understanding of cell therapy manufacturing preferred; cGMP regulations, and compliance requirements (FDA, EMA, GxP) required.o Experience designing and implementing training programs in a complex technical pharma or biotech environment.o Proficiency in Learning Management Systems (LMS) and digital training tools. o Exceptional project management skills with the ability to manage multiple priorities. o Strong communication and collaboration skills to work cross-functionally.o Analytical mindset to assess training effectiveness and drive improvements.o Certification in training and development (e.g., CPLP, CPTM) is a plus.
Personal Qualities & Work Environment
o Detail-oriented, with a strong commitment to quality, compliance, and safety.o Ability to multitask and prioritize effectively in a fast-paced environment.o Strong problem-solving skills and a proactive mindset for process improvements.o Ability to work in cleanroom environments and follow GMP cleanroom protocols.o
The Associate Director, Training Operations will be responsible for the design, implementation, and delivery of learning programs for Orca Bio’s supply chain operations functions. This role is responsible for the strategic planning, development, implementation, and management of the training programs and training compliance for Orca Bio’s cell therapy manufacturing, and related functions. The ideal candidate will bring expertise in training development cycles, instructional design, and compliance-driven training programs while ensuring that all initiatives align with industry regulations and organizational objectives. Responsibilities:
· Training Program Development and Executiono Develop and implement comprehensive, role-based training curricula tailored to Orca Bio’s cell therapy manufacturing.o Ensure training programs comply with GMP, FDA, EMA, and other regulatory requirements.o Oversee the development of hands-on workshops, e-learning modules, SOPs, and regulatory training content.o Collaborate with Subject Matter Experts (SMEs) to ensure training materials are accurate, relevant, and up to date.o Create and maintain training assessments and certification programs to track competencies and ensure compliance.o Drive efficiencies to improve the quality of training programs, reduce costs, optimize scalability, and enhance new employee onboarding.
Training Operations & Compliance
o Oversee the planning and execution of training schedules, ensuring timely and effective delivery.o Manage training logistics, including scheduling, resource allocation, and trainer coordination.o Maintain detailed training records in compliance with regulatory standards.o Ensure training programs support audits and inspections, addressing compliance gaps proactively.o Monitor training KPIs to evaluate program effectiveness and identify areas for improvement. Leadership & Continuous Improvement
o Lead and develop a high-performing training team.o Foster a culture of continuous learning and operational excellence.o Stay up to date with industry best practices and emerging trends to refine training strategies.o Identify opportunities to enhance training methodologies, incorporating blended learning solutions.o Build relationships with key external partners to build and enhance training pipelines Qualifications:
Technical Qualities
o Bachelor's degree in a relevant field such as Biotechnology, Engineering, or Education; advanced degree preferred.o 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. o Strong understanding of cell therapy manufacturing preferred; cGMP regulations, and compliance requirements (FDA, EMA, GxP) required.o Experience designing and implementing training programs in a complex technical pharma or biotech environment.o Proficiency in Learning Management Systems (LMS) and digital training tools. o Exceptional project management skills with the ability to manage multiple priorities. o Strong communication and collaboration skills to work cross-functionally.o Analytical mindset to assess training effectiveness and drive improvements.o Certification in training and development (e.g., CPLP, CPTM) is a plus.
Personal Qualities & Work Environment
o Detail-oriented, with a strong commitment to quality, compliance, and safety.o Ability to multitask and prioritize effectively in a fast-paced environment.o Strong problem-solving skills and a proactive mindset for process improvements.o Ability to work in cleanroom environments and follow GMP cleanroom protocols.o
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