Training Manager

Posting Date 3 weeks ago(2/12/2021 2:59 PM)
Requisition ID
2021-8528
Job Location(s)
Pittsburgh PA United States
Travel
None
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Training

Overview

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

 

The Training Manager is responsible for the development, implementation and maintenance of the training function. Partnering with other departments, the Training Manager ensures that personnel are knowledgeable, qualified and adherent to internal policies, procedures and requirements related to their functional role. This role guides departments to ensure the training program complies with applicable regulatory requirements and industry standards. In addition, the Training Manager champions continuous improvement for training and learning development programs. This role ensures excellence in training practices, adult learning and course development knowledge, human errors management, and commitment to quality processes.

Responsibilities

• Implements and manages the training program to ensure compliance with regulatory requirements

• Collaborates with area management to develop and manages personnel training plans in alignment with employee’s functional role

• Leads the development and implementation of standardized competency-based training program, working in conjunction with functional leaders, subject matter experts and training specialists.

• Analyzes training needs across the organization and ensure ongoing training requirements are delivered to all employees

• Develops, maintains, trends and continuously improves site training program, including conducting effectiveness checks to ensure program applicability

• Identifies learning and training gaps and advises the leadership team on mitigation solutions

• Implements measurement criteria to assess the effectiveness of the training program and report training compliance metrics to management

• Develops multifaceted training delivery methods to utilized varied learning abilities within the workforce

• Acts as site electronic Learning Management System administrator, providing end user support and maintenance of user accounts, learning plans and training items

• Develops process for qualification and disqualification of trainers

• Acts as lead trainer, and/or coordinate training sessions for GMP operations

• Acts as Training impact assessor during document and change control process

• Collaborates with Human Resources team to develop and manage onboarding of new employees, monitor performance of employees and disqualify employees as needed

• Participates as Subject Matter Expert of training processes and training records and reporting during regulatory inspections

• Maintains understanding of new educational and training techniques and methods

• Investigates and responds to Quality System issues identified in the training system

• Oversees team members and support personnel development to ensure essential job functions and duties are performed at high standards

Qualifications

• Undergraduate degree in science or education discipline or 6 years direct, relevant experience in Training to provide a comparable background
• Prior managerial experience in Training and/or Quality

• Minimum of 3-6 years' experience in relevant industry, Quality and/or GMP Training experience
• Thorough knowledge of GxP guidelines and regulations, ICH guidelines, and regulatory compliance

• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing

• Must possess excellent organizational skills, planning, scheduling, the ability to develop and the implement complex processes, procedures and systems

• Demonstrate leadership, critical thinking and ability to develop departmental goals
• Advanced proficiency in MS Office suite
• Maintain composure and competence under stressful situations; flexibility and adaptability 
• Ability to work in collaborative and independent work situations and environments with minimal supervision

 

Physical Requirements:

• Office Setting / No Travel:

• Ability to conduct and hear ordinary conversation and telephone communication.

• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.

• Ability to work under specific time constraints.

• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.

• Visual and manual acuity for working with computers and equipment.

 

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