VEEVA QMS 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.
Candidate must be local to Boston and be able to go into office (hybrid) 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 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.
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is $.
#LI-CG1 At CGI we call our professionals “Partners” 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.
HP Application Lifecycle Mgmt Jira What you can expect from us.
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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.
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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.