Senior Manager, Corporate Quality Training

Organization
PCT, a Hitachi Group Company
Job Location
4 Pearl Ct
Allendale, NJ 07401
Job Description

The Senior Manager, Corporate Quality is responsible for managing the implementation and execution of corporate quality training programs related to key compliance initiatives, applicable regulatory requirements, local and global processes and for the continuous improvement of compliance across PCT Cell Therapy Services. The Senior Manager, Corporate Quality will partner with site personnel and Corporate Quality to ensure that Training and Certificate programs are properly maintained, implemented and communicated across sites. 

Responsibilities: 

• Develop, implement, and manage of Corporate Quality Training Programs that support compliance objectives, applicable to regulatory requirements, local and global processes. 
• Create and manage course curricula and evaluation tools with the objective of maintaining a state of audit readiness and aligning training requirements with business and employee needs. 
• In partnership with relevant parties, identify personnel in-scope of certification, expectations towards certification and customization of the training material if needed. Ensure that course materials are customized and continually revised to accurately reflect organization, regulatory, or business processes changes. 
• Work in partnership with a team of trainers and Subject Matter Experts (SMEs) to ensure that training and certification programs are developed utilizing the most effective methodologies (e.g. Classroom, e-Learning, pre-assessments, and assignments). 
• Ensure that all certification training documentation is consistently and systematically maintained in a timely and effective manner, in compliance with relevant regulations. This includes course materials and training records. 
• Develop and sustain site based training programs governing structure to ensure effective programs ownership and execution at the site level. 
• Develop and maintain training metrics towards measurement of success and effectiveness in collaboration with site personnel. 




• Ensure timely relevant solutions and training programs are in place to address learning requirements, customer needs, and compliance commitments. 
• Support internal, external, regulatory and customer audits when required. 
• Interact with Corporate Quality individuals when needed and work as a member of a team to achieve all outcomes. 
• Maintain systems to track and trend key training effectiveness indicators and ensure monthly KPIs are issued on time and any deficiencies noted are promptly addressed. 
• When necessary, maintain short-term performance goals, training plans, and monitor results to reflect a changing environment. 
• Maintain a working knowledge of eQMS, LMS, and other software’s relevant to the training program to allow proper communication with stakeholders. 
• Develop and maintain curriculum for the training programs in LMS and update when required 
• Identify global learning tools and solutions that enable access to critical learning content “on demand” to support real-time training (websites, shared drives, video tools, etc.) 
• Participate and/or conduct regular Corporate Training update meetings with site training coordinators (forum) as required. 
• Develop and maintain GXP Compliance training system for all sites. 
• All other duties as assigned.



Requirements: 

• Bachelor’s degree (BA/BS) in Life Sciences, Pharmacy, or equivalent required 
• Experience in Industrial Design for e-Learning is required 
• Minimum 5-8 years working in a pharmaceutical QA/QC environment 
• Strong understanding of GMP requirements and their application in a manufacturing environment, knowledge of international GMP requirements a plus. 
• Working experience in design and implementation of training programs, LMS, TrackWise, LIMS is preferred 
• Excellent communication, presentation, technical writing and inter-personal skills 
• Ability to work independently, take initiative and lead, insure and motivate a team 
• Ability to remain focused and effective in high stress situations 
• Computer literate (MS Office, MS Project or equivalent) 
• Must have English language fluency, both written and verbal with the ability to communicate at all levels within the organization.

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