Quality Training Specialist

Job Location: Remote (Anywhere in USA)

Job description:

We are seeking a highly motivated Training Specialist to join our team in the FDA-regulated industry. The ideal candidate will be responsible for aligning internal quality management systems (QMS) with business goals and regulatory compliance needs, ensuring that all training activities meet FDA standards and support continuous improvement. You will design, implement, and maintain training curricula, while also leading audits, gathering feedback, and updating training programs based on findings.

Key Responsibilities:

• Collaborate with business leaders and departments to align training objectives with overall business goals and regulatory compliance requirements, particularly in relation to FDA standards and guidelines
• Ensure that training programs support continuous compliance and foster high-quality performance within the organization.
• Set clear objectives for training programs to ensure they meet organizational needs and compliance standards.
• Lead the design and development of training materials and curriculum frameworks, ensuring alignment with regulatory guidelines, business goals, and industry best practices.
• Develop content for training modules, including presentations, e-learning modules, workshops, and standard operating procedures (SOPs).
• Document all training programs and materials accurately, maintaining records in accordance with FDA and industry-specific compliance requirements.
• Lead periodic reviews of training programs, incorporating feedback and evaluating the effectiveness of training content and delivery.
• Implement updates to ensure that training materials remain current with evolving FDA regulations, company procedures, and business requirements.
• Provide regular reports on training program performance, including attendance, completion rates, and feedback from participants.

Required Skills:

• Bachelor’s degree in quality management, Regulatory Affairs, or a related field.
• Minimum of 3-5 years of experience in training development or a related field, preferably within a regulated industry (FDA-regulated industries such as pharmaceuticals, medical devices, food and beverages, etc.)
• Excellent communication skills, both verbal and written, with the ability to present complex information clearly.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Learning Management Systems (LMS).
• Excellent communication and presentation abilities.
• Ability to work independently while collaborating effectively with cross-functional teams

Life at Capgemini

Capgemini supports all aspects of your well-being throughout the changing stages of your life and career. For eligible employees, we offer: 

• Flexible work 
• Healthcare including dental, vision, mental health, and well-being programs
• Financial well-being programs such as 401(k) and Employee Share Ownership Plan
• Paid time off and paid holidays 
• Paid parental leave
• Family building benefits like adoption assistance, surrogacy, and cryopreservation
• Social well-being benefits like subsidized back-up child/elder care and tutoring
• Mentoring, coaching and learning programs
• Employee Resource Groups 
• Disaster Relief 

About Capgemini Engineering