KEY RESPONSIBILITIES:
1. Develop and Maintain Document Control Systems & Version Control
2. Oversee the process for document creation, review, approval, and distribution, ensuring that documents meet organizational and regulatory requirements.
3. Coordinate with various departments to ensure that documents are reviewed by appropriate subject matter experts (SMEs) and signed off by authorized personnel before they are finalized and implemented.
4. Ensure that approval workflows are followed in compliance with regulatory requirements, including GxP (Good Manufacturing Practices)
5. Offer support to teams in creating and revising documents, ensuring consistency, clarity, and compliance with organizational and regulatory standards.
6. Oversee the complete lifecycle of documents, from creation and revision to archiving and eventual disposal, ensuring compliance with retention policies.
7. Integrate the document control system with the broader Quality Management System (QMS) to ensure that documents are aligned with quality objectives and processes.
8. Collaborate with internal onshore and offshore teams (e.g., quality assurance, regulatory affairs, R&D, manufacturing) to ensure that all quality documents are aligned with the organization's overall quality strategy.
9. Ensure that documents are standardized across the organization, with consistent formats and terminology.
10. Defining training requirements and subject matter content to be administered on a local level. Develop training and deploy training and monitor compliance.
11. Provide training to employees on document control processes and best practices to ensure they understand how to manage and use documents effectively.

Required Skills:
• A bachelor's degree in a related field such as Quality Management, Business Administration, Life Sciences, or Engineering.
• Experience in quality document control, quality assurance, or a related area within a regulated industry (e.g., pharmaceuticals, medical devices, food safety, manufacturing)
• 5-10 years of Quality / relevant process experience in regulatory environment
• 3-8 years of people leadership
• Excellent project management skills in defining scope, schedules, and resources to ensure consistent quality
• Excellent communication and presentation skills with ability to influence people at all levels of the organization
• Ability to identify and resolve document-related issues, whether it's improving workflows, resolving document discrepancies, or addressing regulatory non-compliance

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.