Veeva QMS Business Analyst at CGI Group, Inc.
Cambridge, MA 02140
About the Job
Veeva QMS Business Analyst
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
Together, as owners, let's turn meaningful insights into action.
Life at CGI is rooted in ownership, teamwork, respect and belonging. Here, you'll reach your full potential because...
You are invited to be an owner from day 1 as we work together to bring our Dream to life. That's why we call ourselves CGI Partners rather than employees. We benefit from our collective success and actively shape our company's strategy and direction.
Your work creates value. You'll develop innovative solutions and build relationships with teammates and clients while accessing global capabilities to scale your ideas, embrace new opportunities, and benefit from expansive industry and technology expertise.
You'll shape your career by joining a company built to grow and last. You'll be supported by leaders who care about your health and well-being and provide you with opportunities to deepen your skills and broaden your horizons.
Come join our team-one of the largest IT and business consulting services firms in the world.
Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, height, weight, or any other legally protected status or characteristics.
CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at US_Employment_Compliance@cgi.com . You will need to reference the Position ID of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a Position ID will not be returned.
We make it easy to translate military experience and skills! Click here to be directed to our site that is dedicated to veterans and transitioning service members.
All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held. Dependent upon role and/or federal government security clearance requirements, and in accordance with applicable laws, some background investigations may include a credit check. CGI will consider for employment qualified applicants with arrests and conviction records in accordance with all local regulations and ordinances.
CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI's legal duty to furnish information.
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
Together, as owners, let's turn meaningful insights into action.
Life at CGI is rooted in ownership, teamwork, respect and belonging. Here, you'll reach your full potential because...
You are invited to be an owner from day 1 as we work together to bring our Dream to life. That's why we call ourselves CGI Partners rather than employees. We benefit from our collective success and actively shape our company's strategy and direction.
Your work creates value. You'll develop innovative solutions and build relationships with teammates and clients while accessing global capabilities to scale your ideas, embrace new opportunities, and benefit from expansive industry and technology expertise.
You'll shape your career by joining a company built to grow and last. You'll be supported by leaders who care about your health and well-being and provide you with opportunities to deepen your skills and broaden your horizons.
Come join our team-one of the largest IT and business consulting services firms in the world.
Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, height, weight, or any other legally protected status or characteristics.
CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at US_Employment_Compliance@cgi.com . You will need to reference the Position ID of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a Position ID will not be returned.
We make it easy to translate military experience and skills! Click here to be directed to our site that is dedicated to veterans and transitioning service members.
All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held. Dependent upon role and/or federal government security clearance requirements, and in accordance with applicable laws, some background investigations may include a credit check. CGI will consider for employment qualified applicants with arrests and conviction records in accordance with all local regulations and ordinances.
CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI's legal duty to furnish information.
