GxP Senior Training Specialist

Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market.

At Minaris, you’ll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you’re in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies and make a lasting difference. If you're passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine—one patient at a time.

Position Summary

The Sr. Training Specialist reports to Senior Manager of Quality Systems or above and is responsible for supporting 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 Minaris facilities. The Sr. Training Specialist will partner with site personnel regionally to ensure that Training and Continuous Education programs are properly maintained, implemented and communicated across the site. Collaborates with teams to ensure business objectives are met through effective learning solutions; administers, oversees and organizes LMS curricula.

Essential Functions And Responsibilities

Business Support

• Track, trend and monitor training curriculum compliance
• Manages site GxP training program(s) to ensure compliance with federal, state and local regulations
• Instills continuous improvement related to training materials, programs and processes
• Partner with site technical training representatives and SMEs from other disciplines to create, implement and harmonize processes and procedures
• Support the Minaris Continuing Education system by providing support for continued improvement
• Support audit requests for training reports, as needed.
• Support Global Head, Director of Quality Systems, L&D on all facets of GxP Training
  
  

LMS Administration

• Learning Management system (LMS) Lead Administrator supports and maintains the GxP Compliance training system for employee and external resources.
• Manages general training curriculum for all Minaris personnel that ensures compliant GxP practices
• Monitors and maintains LMS report management, inclusive of creation, addition, and editing for the customer, business, and audits/inspections
• Tracks all LMS updates/release information
  
  

Training Content

• Facilitates learning experiences in multiple delivery modalities including, but not limited to, eLearning, instructor-led training in both in person and virtual environments. This role must demonstrate flexibility to shift between each facet of their role with little difficulty. In addition, this role will stay current with innovative, new learning experience design modalities and be able to create pilot programs based on this research
• Manages and reviews content development requests; such as presentations and computer-based training for business value and project prioritization
• Evaluate training needs and develop eLearning solutions through the application and utilization of various adult learning principles and eLearning technology tools
• Perform other duties as assigned.
  
  

Knowledge, Skill & Ability

• Ability to accomplish the described duties through the use of appropriate computer equipment and software (Veeva, Microsoft Word, Excel, Outlook, and Access).
• Ability to record data accurately and legibly.
• Ability to use judgment as dictated by the complexity of the situation.
• Ability to understand and follow verbal or demonstrated instructions.
• Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
• Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication.
• Proficient in Oral & Written communication skills.
  
  

Education & Experience

• 3-5 years of relevant experience or equivalent
• Bachelors’ degree or equivalent experience
• Strong knowledge and application of adult learning theory and instructional design principles with a strong focus on eLearning/virtual design/graphic design and training methodologies, utilizing the latest interactive learning technologies.
• Strong working knowledge of various authoring and eLearning development tools; i.e., Articulate Storyline, Adobe Captivate, Adobe Connect, PhotoShop, Adobe Illustrator, Adobe After Effects, and/or Adobe Premiere.
• Strong working knowledge of recording and editing audio and using eLearning development tools.
• Ability to author, edit and review Standard Operating Procedures.
• Self-motivated and able to work efficiently with minimal supervision.
• Excellent communication skills, ability to work in a diverse, multi-cultural environment, detail oriented, willingness to “roll up sleeves” and do the work required for success
  
  

Quality Requirements

• Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work.
• Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence.
  
  

Working Environment

This is an onsite Position

Onsite Employees: Employee will work with moderate noise level. Employee will perform tasks while experiencing numerous interruptions. Employee may travel by car and airplane to work at different locations and may occasionally be required to travel overnight. The work environment is fast paced. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off-shift, weekend and overtime duties may be required. While performing the job duties of this job, the employee is regularly required to use English written and oral communication skills.

Physical Requirements

• Must be able to work in an office environment with moderate noise conditions.
• Sedentary work. Exerting up to 20 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. This role involves sitting most of the time utilizing desktop equipment for typing.
• Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have vision sufficient to read materials.
• Must have the ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in person, and on the telephone.
  
  

Special Working Conditions

• May be required to assist in other departments.
• May be required to work weekends or holidays.
• May be required to travel to other Minaris sites for training support.
  
  

Disclaimer

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.

Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more.