Veeva QMS Business Analyst Category: Business Analysis (functional and technical) Main location: United States, Massachusetts, Cambridge Position ID:J1024-0682 Employment Type: Full Time U.S. - Culture, flexibility and purpose By playing this video you consent to Google/YouTube processing your data and using cookies - Learn more. Position Description: • We are seeking a highly skilled and experienced Veeva QMS Business Analyst to join our dynamic team. The ideal candidate will possess in-depth knowledge of both Veeva QMS and Trackwise platforms and have a strong background in using Jira and Agile methodologies. This role is crucial for ensuring the seamless integration and functionality of our quality management systems, and it offers the opportunity to work in a fast-paced, innovative environment. Candidate must be local to Boston and be able to go into office (hybrid) Your future duties and responsibilities: • Analyze business requirements and processes to integrate and optimize Veeva QMS and Trackwise systems within our operations. • Lead the requirement gathering sessions and document detailed functional, technical, and user requirements. • Design and implement effective QMS solutions that comply with regulatory standards and meet organizational needs, focusing on key processes like deviation, change control, CAPA, lab investigations, complaint handling, audits and inspections, supplier quality management (SQM), and quality risk management (QRM). • Utilize Jira to manage project tasks, track progress, and collaborate with cross-functional teams to ensure deliverables are met according to Agile practices. • Conduct data analysis and migration activities, ensuring data integrity and system efficiency between Veeva QMS and Trackwise. • Develop and maintain inbound and outbound interfaces for data streams related to ERP systems (SAP, ECC/S4, JDE), Data Lakes, regulatory systems, local complaint systems, clinical and pharmacovigilance systems, and ServiceNow. • Facilitate effective communication between internal teams and external vendors to address system issues and enhancements. • Develop training materials and provide training sessions to end-users to ensure smooth transition and adaptation to the new system features. • Continuously monitor system performance and user feedback to recommend improvements or adjustments as needed. • Stay updated with the latest developments in QMS technologies and Agile methodologies to drive innovation and efficiency within the team. Required qualifications to be successful in this role: • Bachelor's degree in Computer Science, Information Systems, Business Administration, or related field. • Proven experience as a Business Analyst with specialized experience in Pharma QMS and specific to Veeva QMS and Trackwise. • Strong technical skills, including experience with data migration and system integration. • Proficient in Jira and Agile methodologies with a proven track record of managing projects in an Agile environment. • Excellent analytical, problem-solving, and communication skills. • Demonstrable ability to handle multiple tasks under tight deadlines. • Prior experience in the pharmaceutical or life sciences industry is highly desirable. • Minimum 7 years of experience in Quality Management System implementations, with at least 5 years focused on Veeva QMS. • Proven track record of successful Veeva QMS implementations and data migrations. • Strong understanding of regulatory requirements related to QMS in industries such as pharmaceuticals, biotechnology, or medical devices. • Excellent problem-solving skills and the ability to handle complex technical challenges. • Strong communication and presentation skills, capable of working effectively with both technical and non-technical stakeholders. • Certification in Veeva and Trackwise would be preferable #LI-CG1 CGI is required by law in some jurisdictions to include a reasonable estimate of the compensation range for this role. The determination of this range includes various factors not limited to skill set, level, experience, relevant training, and licensure and certifications. To support the ability to reward for merit-based performance, CGI typically does not hire individuals at or near the top of the range for their role. Compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range for this role in the U.S. is $84,000 - $161,600. At CGI we call our professionals members to reinforce that all who join our team are, as owners, empowered to participate in the challenges and rewards that come from building a world-class company. CGI's benefits include: • Competitive base salaries • Eligibility to participate in an attractive Share Purchase Plan (SPP) in which the company matches dollar-for-dollar contributions made by eligible employees, up to a maximum, for their job category • 401(k) Plan and Profit Participation for eligible members • Generous holidays, vacation, and sick leave plans • Comprehensive insurance plans that include, among other benefits, medical, dental, vision, life, disability, out-of-county emergency coverage in all countries of employment; • Back-up child care, Pet insurance, a Member Assistance Program, a 529 college savings program, a personal financial management tool, lifestyle management programs and more Skills:
- Business Analysis
- Database
- Quality Management
- SQL
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