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Job Title: Veeva Quality Management System (QMS) Consultant

Job Location: Remote

Full Time Employment with Capgemini Engineering

Job Description:

We are seeking a highly motivated Veeva Quality Management System (QMS) Consultant to support the implementation, maintenance, and optimization of our quality management processes using the Veeva Vault QMS platform. The ideal candidate will have a strong background in quality assurance, a thorough understanding of regulatory compliance, and hands-on experience with Veeva QMS. This role will involve ensuring that quality processes are effectively integrated into all aspects of our operations, fostering a culture of continuous improvement and compliance.

Key Responsibilities:

· Assist the sales team with pre-sales technical knowledge and presentations.

· Understand customer requirements and provide sales support.

· Conduct product demonstrations, both online and face-to-face.

· Identify and understand the specific needs of clients.

· Design and develop tailored solutions that meet client requirements.

· Prepare and present proposals to clients.

· Respond to technical and functional product queries during the sales process.

· Work closely with the sales team and other departments to ensure coordination and smooth execution of sales processes.

· Train the sales team on the technical aspects of the product or service.

· Quality Management System Oversight:

o Manage the lifecycle of quality documents, including policies, procedures, work instructions, and forms within the Veeva Vault QMS.

o Ensure that all quality documentation is compliant with relevant regulations and industry standards (e.g., ISO, FDA, GxP).

· System Configuration and Maintenance:

o Configure and customize Veeva Vault QMS to align with organizational quality processes and workflows.

o Monitor system performance and coordinate with Veeva support for any issues or enhancements.

· Process Development and Improvement:

o Develop, implement, and maintain standard operating procedures (SOPs) and workflows to enhance quality management practices.

o Identify opportunities for process improvement and automation within the quality management system.

· Training and Support:

o Provide training and support to users on Veeva QMS functionalities and quality processes.

Develop user guides and training materials to facilitate effective use of the QMS.

· Regulatory Compliance and Audits:

o Ensure compliance with quality standards and regulations through regular monitoring and assessment of quality processes.

o Participate in internal and external audits, providing necessary documentation and evidence of compliance.

· Data Management and Reporting:

o Maintain accurate records of quality metrics, investigations, and corrective and preventive actions (CAPAs).

o Generate reports and dashboards to communicate quality performance and trends to management.

· Cross-Functional Collaboration:

o Collaborate with various departments, including Manufacturing, Research & Development, and Regulatory Affairs, to ensure alignment of quality processes across the organization.

o Act as a quality liaison to address quality-related inquiries and support investigations.

Job Requirements:

· Strong understanding of quality management principles, practices, and regulatory requirements.

· 5 years of experience in Veeva Suite, Quality Documents, QMS, Vault training.

· Veeva Admin Certification is required

· Good Presentation skills for conducting product demonstrations.

· Excellent analytical and problem-solving skills, with attention to detail and accuracy.

· Strong communication and interpersonal skills, with the ability to work collaboratively across 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: Developer

Organization: ERD PPL US

Title: Veeva Quality Management System (QMS) Consultant

Location: MA-Boston

Requisition ID: 077233