Veeva QMS QA Lead

2 weeks ago

Boston, United States Vlink Full time
Position: Veeva QMS QA Lead
Location: Boston, MA- Hybrid
Duration: Long Term Contract

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 Client 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 Client 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 Client 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

Employment Practices:
EEO, ADA, FMLA Compliant VLink is an equal opportunity employer. At VLink, we are committed to embracing diversity, multiculturalism, and inclusion. VLink does not discriminate on the basis of race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. All aspects of employment including the decision to hire, promote, or discharge, will be decided on the basis of qualifications, merit, performance, and business needs.

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