GxP Training Manager

Agios Pharmaceuticals   •  

Cambridge, MA

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 32 days ago

Agios is searching for a GxP Training Manager to assist in the operational production and support overall strategy of the GxP training function. The GxP Training manager will also assist in providing development, implementation and maintenance of systems and processes for GxP training records in compliance with current GxP regulations in US / EU. The right individual willensure the system is current, standardized, in a state of compliance, and aligned with industry best practices. This individual will have the opportunity to develop and deliver training on GxP topics such as new hire training and train-the-trainer and influence the design, development, and delivery standards for learning programs through interface with business counterparts and key Subject Matter Experts. Success in this role depends on the ability to demonstrate solid understanding of business acumen, partnering with the organization on transformation by supporting change management, developing colleagues through coaching, supporting the organization with competency management, evaluating learning impact, and ability to demonstrate performance improvement through strong needs analysis to identify human performance solutions.

Responsibilities:

  • Manage the site training system to ensure compliance readiness at all times.
  • Develop and deliver training using novel and traditional techniques to ensure employees are engaged and learned in their role.
  • Maintenance of all training records across multiple departments through interface with business counterparts and participates in the identification and development of programs and projects that drive organizational and individual performance.
  • Measures, reports and influences the effectiveness of the location's/global function's training system to management through consultation and participation in metrics meetings and represents the location/global function in the development of the network training plan.
  • Responsible for assuring quality and consistency in the information being delivered, provide direction on policies, procedures, and practices, and interprets the execution of them.
  • Compile and present information including KPI's which reflect success of program training, value to the business and related trends, utilizing both internal and external bench-marking. Maintain a keen understanding of training trends, developments and best practices, and present to management teams the training program's return on investments. React to those metrics to ensure compliance with the training program.
  • Ensure the availability of business reports and metrics pertaining to program activities/progress that inform management decision-making.
  • Build and maintain working relationships with business process owners, subject matter experts (SMEs) to create review and edit training materials, facilitating the timely accomplishment of project deliverables. Assist with strategic planning activities to proactively provide effective and efficient learning solutions to business areas. Partner with other departments to develop training strategies and support them in the development of employee training curricula, qualification programs and associated materials. Manage the philosophy and development of learning plans and curriculum to align with the competency framework.
  • Define current state environments, understand future state needs, and define training plans to address gaps. Continually evaluate effectiveness of current programs and conduct ongoing skills and needs assessments.
  • Evaluate, test and recommend continuous improvement initiatives, such as the investment in content development tools, delivery methods, learning technology solutions and the evolution of the overall training system for efficiency and efficacy. Introduce new training ideas into the organization, adapts new ideas and converts them into approaches that meet training/regulatory challenges.
  • Manage complex and multiple projects, including developing timelines, milestones, responsibilities and overall stakeholder relationships.
  • Develop, communicate and implement the Site Master Training Plan.
  • Maintain a cGxP training program for all newly hired personnel.
  • Responsible for delivery and improvements to annual GxP Refresher Program for all GxP employees. Assure compliance with minimum training requirements.
  • Ensure that trainers are qualified and support the "Train the Trainer" program.
  • Participate in internal audits and Regulatory agencies' inspections.
  • Ensure effective and timely Training program investigations are performed as well as appropriate CAPA's implemented to prevent reoccurrence.
  • Other duties as assigned

Qualifications and Skills Required:

  • Bachelor's degree with 8+ years experience in a GxP regulated environment, at least 5 of which in a training role performing work that requires strong analytical, consultative and diagnostic skills and ability to make sound, data-based business decisions.
  • Experience managing training projects with multiple subject matter experts
  • Strong content knowledge in cGxP/regulatory compliance
  • Proven ability to work as part of a well-integrated, networked team and collaborate across functional, organizational, and location boundaries.
  • Strong written and verbal communication skills. Ability to communicate at all levels within the organization
  • Capable of building strong relationships, and influencing without direct authority
  • Drive to build external networks - developing and cultivating relationships with external development groups and learning providers
  • Able to create structure around ambiguous assignments and manage complexity in terms of the work and stakeholders to deliver results in a compressed timeframe
  • Must be innovative and courageous to challenge the status quo
  • Strong foundation in problem solving, analytics and project management principles and tools

Preferred Qualifications:

  • Master's level degree in related field preferred
  • Working knowledge of ComplianceWire e-learning management system