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

World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 55,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet.

Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of €22.5 billion.

Get the Future You Want | www.capgemini.com

Disclaimer

Capgemini is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.

This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodations do not pose an undue hardship.

Capgemini is committed to providing reasonable accommodations during our recruitment process. If you need assistance or accommodation, please reach out to your recruiting contact.

Click the following link for more information on your rights as an Applicant http://www.capgemini.com/resources/equal-employment-opportunity-is-the-law

Please be aware that Capgemini may capture your image (video or screenshot) during the interview process and that image may be used for verification, including during the hiring and onboarding process.

Applicants for employment in the US must have valid work authorization that does not now and/or will not in the future require sponsorship of a visa for employment authorization in the US by Capgemini.

Job: Programmer/Analyst

Organization: ERD PPL US

Title: Quality Training Specialist

Location: TN-Nashville

Requisition ID: 078572