Manager, Training Operations
Xellia

Cleveland, Ohio

This job has expired.


The Manager, Training Operations will have the responsibility to deliver relevant, effective training for operations employees at Xellia's Cleveland site, which is necessary to perform their jobs and supports the learning goals of the site. Assignments are received in project and objective-oriented terms, and results may be accomplished through internal, cross-functional partnerships.

The position holder will execute Xellia's learning and training strategy at the Cleveland site, applying verifiable learning methodology and instructional design principles. The position requires a hands-on individual who is results-oriented and motivated to perform at a very high level.

Key Responsibilities

  • Administers training and development programs designed to promote a culture of learning
  • Partners with Quality leaders and People & Organization leaders on designing training and development programs
  • Connects global and local resources when structuring training and development programs
  • Applies design thinking to the creation and development of training materials to support across all Operations at the site
  • Lead the "Train-the-Trainer" program, and support the continuous development of area trainers to ensure high-quality, consistent training delivery
  • Maintains programs in alignment with current compliance expectations, procedures, and best practices
  • Provides leadership and support to management at the site on recommended, competency-based training and development programs
  • Works closely with the Cleveland Site Leadership Team to identify needs, establish priorities, and monitor performance to training goals
  • Conducts needs analysis and training effectiveness checks, and reporting on the results
  • Works closely with area managers to assist with standardizing, developing, and implementing competency-based training programs which align with Xellia's training strategy
  • In conjunction with Compliance Quality Assurance (CQA), administers and reports on training in the Learning Management System (LMS)
  • Ensure projects are completed on schedule and within budget
  • Maintains the Cleveland Site Training Center and communicating about materials, furnishings, or supplies that are needed
  • Occasionally accesses locations within the manufacturing facility that could have moderately disagreeable features such as noise, heat, or production conditions
  • Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in cGMP compliance, establish systems that identifies opportunities for improvement, and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMPs, FDA, OSHA and other regulatory agencies.

Requirements
  • At minimum, Bachelor's degree in education, related-scientific discipline or similar
  • 6+ years of professional experience, pharmaceutical industry preferred
  • 6+ years of experience developing, delivering and assessing classroom, computer-based, and competency-based training
  • Computer literacy: must be proficient in Microsoft Office (i.e. PowerPoint, Excel, Word, etc).
  • Proven needs analysis, instructional design, and facilitation skills
  • Strong verbal and written communication skills
  • Proven influencing skills for stakeholder management across organizational levels
  • Learning focused and service oriented
  • Experience with root cause analysis, change management, and process improvement preferred
  • Experience with process optimization strategies, as nice to have (i.e. Lean, Six Sigma)

Physical Requirements of the Role

Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

Position is exposed to several environments, office, lab, outside, plant floor, etc. Candidate must be able to frequently sit, stand, and walk. This role is continuously sitting and typing. Frequently talking and using eye and hand coordination. Occasionally bending over, crawling, climbing, reaching, kneeling, pushing, and pulling. Also, must be able to carry 10-25 lbs frequently.

Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients' quality of life. Together with us, you can help lead the fight against bacterial infections.

Read more about Xellia Pharmaceuticals here


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