Training and Development Manager

The Training & Development Manager is responsible for designing, delivering, and managing a robust New England training program across the departments and the sites to help achieve the goal of providing outstanding education and training across the organization.  

Core Responsibilities:                                                                                                                   

• Develop, evaluate, and deliver high quality training programs across all functions and support external training by cross functional teams.
• Design and develop employee training that aligns with the company’s values and business goals.
• Building and maintaining the training systems for New England, including leadership development and skills development training, and leading programs directly related to the retention and professional enhancement of our team members.
• Provide guidance and leadership to a site Training Committee made up of supervisors from all relevant departments.
• Collaborate with internal and external subject matter experts to develop and deliver hands-on, On-the-Job-Training (OJT) content for our departments and team members.
• Manage training documents within the controlled document system ensuring that all required training documentation is retrievable, accurate, complete and well organized.
• Handle all supporting activities for implementation and maintenance of controlled training documents including periodic review, training assignment management, and archival.
• Collaborate with a cross-functional team to address training and documentation needs, confirm alignment across existing procedures, and ensure training assignments are appropriately set for teams and individuals.
• Define, develop and track department training metrics and report their status to the Site Director on a regular basis.
• Maintain and implement improvements to the education and training program to ensure compliance with global initiatives and cGMP.
• Support computer system training activities related to the quality system.
• Support the QA department in meeting quality objectives and regulatory requirements.
• Participate in inspection readiness activities and assist with corporate and internal audits and regulatory inspections.
• Own training and development strategies, including scope of programs, budgets, and more.
• Partner with all levels of management in each department to ensure that all training activities, training plans, and other training requirements are completed on time.
• Develop and maintain participant and instructor materials (course manuals, workbooks, handouts, job aids, etc.), and manage an integrated curriculum.
• Manage, administer, and track training plans and training matrices (collaborating with department managers) in MasterControl or another suitable system.

Qualifications: 

Required

• Bachelor's or master's degree
• Minimum seven years of relevant experience developing and administrating a training program
• Extensive knowledge of SOPs and GMPs and the know-how to work and manage within a regulated environment
• Prior experience with MasterControl or similar programs
• Strong change management skills and demonstrated ability to simplify and improve business processes
• Adaptable to a fast-paced, complex, and ever-changing business environment
• Practical verbal and written communications skills
• Solid organizational skills and attention to detail
• Self-motivated, self-disciplined, and able to function independently and as part of a team
• Excellent computer proficiency (MS Word, Excel, PowerPoint, etc.)

Preferred

• Biotech/pharmaceutical/GMP industry or expertise in a highly regulated environment is strongly preferred