Senior Quality Assurance Specialist – CSV (Clinical Research)
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.comor follow MMS on LinkedIn.
Job Description
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).
Job 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.
Exposure to Regulatory Technology (RegTech) systems or electronic document management systems (EDMS) is preferred.
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Senior Quality Assurance Specialist – CSV (Clinical Research)
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.comor follow MMS on LinkedIn.
Job Description
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).
Job 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.
Exposure to Regulatory Technology (RegTech) systems or electronic document management systems (EDMS) is preferred.