Senior Quality Assurance Specialist

Summary

Join MMS, an award-winning, data-focused CRO, and be part of a supportive, innovative team that values its employees. We offer a collaborative and inclusive work environment with an industry-leading customer satisfaction rating. As a Computer System Validation (CSV) Lead, you will play a crucial role in ensuring compliance with GxP, 21 CFR Part 11, and other regulatory guidelines. This position requires strong leadership, documentation, and communication skills, along with extensive experience in CSV within the clinical research or pharmaceutical domain. You will lead and support CSV activities across clinical systems, create validation documents, collaborate with cross-functional teams, and participate in audits and inspections. MMS is committed to fostering a culture of excellence and providing opportunities for professional growth.

Requirements

• Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred
• 7-10 years of experience in Computer System Validation (CSV)
• Prior experience in the clinical research or pharmaceutical domain is a must
• Hands-on knowledge of GAMP 5, GxP, 21 CFR Part 11 and other applicable regulations
• Excellent documentation and communication skills
• Detail-oriented, process-driven, and proactive in identifying risks or gaps
• Understanding of CROs and scientific and clinical data/terminology
• Excellent ability to multitask, attention to detail, and organizational skills

Responsibilities

• Lead and support Computer System Validation (CSV) activities across clinical systems (e.g., EDC, CTMS, LIMS). Acts as SME
• Create, review, and manage validation documents such as Validation Plans, Test Scripts, Traceability Matrix, and Reports
• Ensure compliance with GxP, 21 CFR Part 11, and other regulatory guidelines related to system use in clinical environments
• Collaborate with IT, QA, and Functional Leads to ensure quality and regulatory expectations are met during system implementation or change
• Participate in internal and external audits, and provide documentation support during regulatory inspections
• Contribute to SOP development, risk assessments, and periodic reviews
• Maintains a strong understanding of regulations and guidance as they pertain to compliance; mentors others; advises on MMS updates related to regulatory updates
• Proficient in authoring QMS related documents, i.e. SOPs, Work Practices, Forms, Training Materials, etc. independently; mentors others; acts as SME
• Develop CAPA plans and contribute to resolution of audit findings independently; mentors others; acts as SME
• Monitor vendors to ensure CSV processes are followed and quality is maintained independently, mentors others; acts as SME
• Assists in internal process and document QA audits per procedure independently and in collaboration; mentors others; acts as SME
• Ability to support document development (SOPs/ WPs)
• Support timely maintenance of multiple QMS trackers, creation & updates to Ops meetings applicable (PowerPoint)

Preferred Qualifications

Exposure to Regulatory Technology (RegTech) systems or electronic document management systems (EDMS) is preferred