KEY RESPONSIBILITIES:
1.Review Tobacco product and process changes to ensure they are necessary, and initiate the change control process when required. This could involve changes to the product design, formulation, manufacturing processes, or packaging.
2.Oversee and manage the company's change control system, ensuring that all product changes are tracked, evaluated, and implemented in a structured and controlled manner.
3.Ensure that changes are documented thoroughly, including rationale, risk assessments, potential impact on product quality, and regulatory compliance
4.Track and manage changes from initiation through approval, implementation, and closure, ensuring they meet all internal and regulatory requirements
5.Assess the potential impact of proposed changes on Tobacco product quality, patient safety, regulatory compliance, and other key areas. This includes evaluating how changes may affect manufacturing processes, supply chains, or product performance
6.Work with departments like Quality Assurance (QA), Regulatory Affairs, R&D, Manufacturing, and Supply Chain to evaluate the impact of the proposed changes on the product and its intended use
7.Develop and maintain change control documents such as Change Control Forms, Risk Assessments, Impact Analysis Reports, and approval records.
8.Keep stakeholders informed throughout the change control process, providing updates on the status of change requests and any risks or issues that arise.
9.Once the change has been successfully implemented and verified, ensure that the change control request is closed and all documentation is archived as required

Required Skills:
• A bachelor's degree in a relevant field such as Computer Science, Life Sciences, Engineering, or a related discipline.
• A strong understanding of regulatory standards such as 21 CFR Part 820 (medical devices), 21 CFR Part 211 (pharmaceuticals), ISO 13485 (medical devices), ISO 9001 (quality management), and other applicable standards
• Knowledge of how changes in Tobacco product design, manufacturing processes, or packaging affect regulatory compliance and reporting
• Strong organizational skills and the ability to manage multiple changes concurrently, ensuring that they are completed on time and within compliance.
• 3-7 years of Quality / relevant process experience
• Ability to lead and manage a team
• Ability to succeed in environment with conflicting priorities

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.