Veeva QMS Validation and QA Lead

Position Description:

The Validation and QA Lead will be responsible for managing the validation activities, quality assurance processes, and regulatory compliance for pharmaceutical projects. This role requires a minimum of 8 years of experience in the pharmaceutical industry, specifically in Quality Management Systems (QMS), using tools such as Veeva or Trackwise, and expertise with HP ALM for validation activities. The successful candidate will also be responsible for leading and mentoring both offshore and onshore resources to ensure successful project delivery.

This is a Full Time Employment Opportunity with CGI based in Burlington, MA in a hybrid model.

Your future duties and responsibilities:

• Lead and manage validation and QA activities for the organization’s Quality Management Systems (QMS), ensuring compliance with pharmaceutical regulatory requirements (FDA, EMA, etc.).
• Oversee the implementation and validation of systems using Veeva or Trackwise for QMS processes.
• Ensure compliance with GxP and 21 CFR Part 11 regulations, and lead validation efforts using tools such as HP ALM to maintain validation traceability and documentation.
• Develop and execute validation plans, test scripts, protocols (IQ, OQ, PQ), and reports to ensure compliance with quality standards.
• Manage end-to-end software validation lifecycle for QMS implementations, upgrades, and ongoing support, including risk assessment and mitigation strategies.
• Collaborate with cross-functional teams, including IT, business, and regulatory departments, to define validation requirements and ensure adherence to quality standards.
• Manage, mentor, and guide offshore and onshore validation and QA resources to ensure project goals are met on time and within scope.
• Ensure efficient communication and collaboration between offshore and onshore teams to maintain alignment on deliverables and objectives.
• Review and approve validation deliverables, including test scripts, validation protocols, deviations, and corrective actions.
• Implement best practices and continuous improvement initiatives to enhance validation processes and quality assurance activities.
• Act as the primary point of contact for audits and inspections related to validation activities, ensuring audit readiness at all times.
• Stay up-to-date with industry trends and regulatory changes to ensure that all validation and QA processes are current and compliant.

Required qualifications to be successful in this role:

• Bachelor’s degree in Life Sciences, Computer Science, Engineering, or related field.
• Minimum of 8 years of experience in quality assurance and validation within the pharmaceutical industry.
• Extensive experience working with Quality Management Systems (QMS) and tools such as Veeva or Trackwise.
• Strong experience with validation processes and documentation, including IQ, OQ, PQ, and use of HP ALM for test management and traceability.
• In-depth knowledge of GxP, 21 CFR Part 11, and other relevant pharmaceutical regulations.
• Proven ability to lead and manage both offshore and onshore validation and QA teams.
• Excellent project management skills with the ability to manage multiple projects simultaneously.
• Strong problem-solving skills and the ability to mitigate risks effectively.
• Excellent written and verbal communication skills, with the ability to collaborate across different functions and regions.
• Experience managing external audits and ensuring regulatory compliance readiness.

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Other Information:

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 $86,200.00 - $145,500.00.

CGI’s benefits are offered to eligible professionals on their first day of employment to include:
• Competitive compensation
• Comprehensive insurance options
• Matching contributions through the 401(k) plan and the share purchase plan
• Paid time off for vacation, holidays, and sick time
• Paid parental leave
•Learning opportunities and tuition assistance
• Wellness and Well-being programs

Skills:

• Quality Management
• SQL

What you can expect from us:

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.