uniQure

Training Manager, Quality Assurance - Lexington, MA

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Active since 07-11-2017 Job category Quality / Health / Environment ...
Location Lexington, MA Level Professional
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
The Position: 

The Quality Assurance Training Manager provides leadership in the development, implementation and maintenance of the Quality Training Program in support of the Quality Management Systems (QMS). The position is primarily responsible for management of the GxP Training Program and administration of the electronic learning system management system, Employability Manager (EMMA). The position will work in collaboration with QA management and other departments to develop and implement the GxP training program.

A summary of the major responsibilities:

  • Develop and implement the corporate strategy for GxP Training
  • Develop and implement competency-based training program in support of the Quality Management System
  • Conduct competency mapping and job task analysis
  • Review and evaluate training program and materials to ensure compliance with applicable FDA and other regulatory agency requirements and guidance documents
  • Design and Develop Quality System focused onboarding orientation to include annual GxP training
  • Develop and Administer Qualified Trainer Program to include Train-the-Trainer course
  • Develop and analyze KPIs and metrics to evaluate program effectiveness
  • In collaboration with business process owners and subject matter experts, design learning, implementation, and communication plans ensuring sustainability of training
  • Conduct ongoing and comprehensive documentation and training needs assessment ensuring global process improvement
  • Collaborate with functional area management to develop, implement, and revise OJT Program to include process and documentation
  • Establish and maintain quality training matrices including functional areas, core training, and regulatory training matrices
  • Partner with functional areas to conduct ongoing needs analysis, training effectiveness checks, learning transfer, and trends results as appropriate
  • Perform annual curriculum review

Qualifications:

  • Bachelor’s degree or equivalent work experience (minimum 5-8 years)
  • 5+ years’ experience in quality training environment
  • 3+ years’ experience in Biotech
  • Experience designing and implementing curricula preferred
  • Excellent team-building, organization and leadership skills

Core Competencies:

  • Must have exceptional presentation and facilitation skills
  • Working knowledge of Adult Learning Theory and Kirkpatrick methods of evaluation
  • Biotechnology experience preferred
  • Prior experience in cGMP Manufacturing or Quality Operations.
  • Working knowledge of LMS and e-Learning tools preferred.
  • Experience developing, delivering and assessing classroom, computer-based, and competency based functional training.
  • Strong knowledge of MS Word and PowerPoint
  • Solid organizational and time management skills
  • Advanced knowledge of global, especially US and EU GCP and GLP guidelines.
  • Confident, independent, self-starter, proactive, and results-oriented with high performance standards.
  • Strong ability to prioritize and operate with a sense of urgency.
  • Effective communication skills with the ability to interact with all levels of the key stakeholder with demonstrated interpersonal skills.
  • Demonstrated ability to effectively solve problems and implement practical solutions in a dynamic and innovative environment
  • Exhibits highest integrity and committed to ethics and compliance standards
  • Strong emotional intelligence
More information
This listing is a full-time job

Job category Quality / Health / Environment / Safety
Industry / Industries Biotechnology
Region United States
Keywords Quality Assurance, Training

Contact information

Name Jennifer Wagner

Location

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