Job Description

**Position Summary:

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The Learning Excellence Specialist is responsible for assessing the skills, performance, productivity and talents of employees in the Rockville site of the Client CDMO business. The incumbent will partner with Corporate Learning, Site Leadership and Quality to ensure strategy and execution are in accordance with Corporate and Site policies and goals as well as compliance with GMP requirements.

**Key Responsibilities and Duties:

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• Consult with Site Management and Subject Matter Experts to define applicable learning objectives and assign appropriate training curriculum and course content
• Evaluate the effectiveness of learning initiatives through metrics, feedback, and performance data, and implement recommendations for continuous improvement to training
• Ensure all training is documented and training records are maintained according to GMP and Company practices and policies
• Ensure strategic alignment of the training department with business goals
• Optimize training processes for efficiency
• Support client and regulatory audits
• Manage vendors that provide training material or conduct training
• Manage the LMS used for training
• Foster a culture of continuous learning and professional development throughout the organization, encouraging employees at all levels to take ownership of their growth and development
• Effectively model, demonstrate and live an employee-focused leadership style that prioritizes compliance, respectful and professional cross departmental collaboration, accountability, and the well-being, personal, and career development of each employee
• Perform all other related duties as assigned.

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**Qualifications:

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• Bachelor's degree (B.A./BS.) required in Learning, Education, Human Resources or a related field.
• Three plus years related experience in learning solutions in different modalities; specific experience in a cGMP laboratory facility (pharmaceutical or biotech) training environment a plus
• Three years of experience in managing Learning departments that include design, delivery and LMS administration, preferred
• Proven platform/facilitation skills
• Familiar with Blooms Taxonomy, Kirkpatrick Model, ADDIE and SAM.
• Two to Four years of experience utilizing an LMS
• Technical writing experience required
• Proficiency with MS Office applications and the ability to learn various software packages
• Ability to maintain a high degree of accuracy and attention to detail.
• Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively.
• Demonstrated project management skills
• Understanding/familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with biologic/cell therapies.
• In-depth understanding of regulations and Good Manufacturing Practices; knowledge of applicable regulations and standards affecting Pharmaceutical Products including familiarity with FDA approval procedures preferred

You should be proficient in:

• Bachelor's Degree
• Good Manufacturing Practices (GMP)