MMS

Regulatory compliance and data solutions provider

Senior Software QA Tester

Manual & Functional QAConfirmed live in the last 24 hours

Full-timeIndiaNo salary listed

About the Job

Requirements

A graduate degree in a scientific, medical, or clinical discipline or a related field, or related experience.
Five to eight years of experience in software quality or testing.
Understanding 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 test scenarios, risks, or gaps.
Ability to multitask, maintain attention to detail, and stay organized.
Ability to understand technology and software and design a testing approach.
This is a manual testing role; automation testing is not involved at this time.
Work hours are 1 p.m. to 10 p.m. IST.

Responsibilities

Lead and support computer system and software testing activities across clinical systems utilized by MMS, acting as a subject matter expert in testing.
Create, review, and manage test documents, including test plans, test scripts, traceability matrices, and test reports.
Ensure compliance with user requirements, 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 user and system requirements are met during system implementation or changes.
Maintain a strong understanding of the software development lifecycle, software testing lifecycle, and defect lifecycle practices and guidelines; mentor others and advise on testing approaches as needed.
Independently author test-related documents, including plans and scripts; mentor others and act as a subject matter expert.
Support development of standard operating procedures and work practices.
Create, update, and maintain multiple software and system defect trackers, and present status to senior leadership.
Communicate with organizational users about product-related issues.
Support the capture of project requirements.
Review scoped requirements and design solutions and proactively provide feedback.
Execute assigned tasks with quality and integrity.
Communicate proactively and clearly with technical and non-technical stakeholders.
Manage end-user product support issues through resolution.
Apply processes to identify, initiate, and write test plans that support product-development quality.
Apply continuous integration and continuous delivery practices to support quality features and product development.
Contribute to testing processes, drive continual improvement, lead meetings, and develop knowledge in others.
Create and review tests and provide guidance to ensure consistency in testing, QA best practices, and standards; support more junior colleagues.
Contribute to development of, and potentially review, current policies, procedures, and company standards.
Anticipate potential quality and compliance issues and seek appropriate support to address or mitigate them.
Ensure project deliverables are completed within agreed timescales and formally accepted by appropriate stakeholders.
Agree approaches with stakeholders across projects and liaise with the manager to prepare realistic plans.
Understand workflows and dependencies for development of project timelines.
Participate in all project stages and understand workflows and dependencies of project timelines.
Identify risks, proactively mitigate them, and advise team members where applicable.
Ensure quality reviews occur according to procedure through the testing and QA function.
Support team- and company-related activities and initiatives.

Desired Qualifications

Prior experience in clinical research or the pharmaceutical domain.

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.com or follow MMS on LinkedIn.

Roles & Responsibilities

Lead and support Computer System/Software testing activities across clinical systems utilized by MMS. Acts as SME as related to testing.
Create, review, and manage test documents such as Test Plans, Test Scripts, Traceability Matrix, and Test Reports.
Ensure compliance with User Requirements, 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 user and system requirements are met during system implementation or changes.
Maintains a strong understanding of SDLC and STLC, Defect Lifecycle practices and guidelines; mentors others; advises on testing approach as needed.
Proficient in authoring test related documents, i.e. Plans, Scripts, etc. independently; mentors others; acts as SME.
Ability to support document development (SOPs/ WPs).
Creation, updates, timely maintenance of multiple Software/System defect trackers, status presentations to senior leadership.
Communicate with various users across the organization on issues related to product.
Supports the capture of project requirements.
Review and proactively provide feedback on scoped requirements, design solutions.
Execute assigned tasks with high quality, integrity, and attention to detail.

Interact regularly with a broad range of stakeholders, communicating proactively and clearly, including technical and non-technical subjects.
Communicates with end-users on issues related to product support, can manage support issues though to resolution.
Proactively applies process to identify, initiate, and write test-plans, to support quality across product development.
Proactively applies the application of CI/CD to support quality features/product development.
Actively contribute to testing processes, drives continual improvement, leads meetings, and actively develops knowledge in others.
Create, reviews and provides guidance to ensure consistency in a test, and QA, best practice, and standards, supporting more junior colleagues in these activities.
Contribute to development of, and may perform review of current policies, procedures and company standards.
Anticipates potential quality and compliance issues and seeks appropriate support to address/mitigate.
Ensure project deliverables are completed within agreed timescale and are formally accepted by appropriate stakeholders.
Agree approach with stakeholders on a variety of projects and liaise with Manager to prepare realistic plans.
Understand all workflows and dependencies for the development of project timelines.
Actively participate in all stages of the project and understands all workflows and dependencies of project timelines.
Identifies risks, proactively mitigating, advising team members where applicable.
Ensures quality reviews occur according to procedure via the testing and QA function.
Support team and company related activities and initiatives.

Job Requirements:

Graduate degree in scientific, medical, clinical discipline or related field, or related experience.
5-8 years of experience in Software Quality/Testing. Prior experience in clinical research or pharmaceutical domain preferred.
Understanding 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 test scenarios, risks or gaps.
Excellent ability to multitask, attention to detail, and organizational skills.
Excellent ability to understand technology/software and design testing approach.

Note:

This is a manual testing role. NO Automation testing involved at this time.
Need to work till 1pm to 10pm IST

About the Company

MMS

Regulatory compliance and data solutions provider

MMS Holdings is a global contract research organization (CRO) focused on regulatory compliance and data-driven solutions for pharmaceutical and biotech sponsors. It delivers services such as regulatory submissions, clinical trial management, data analytics, and medical writing through a service-based model that relies on established processes and experienced advisors. Its work is contract-based, often long-term, aimed at helping clients meet regulatory requirements, run trials efficiently, and advance therapies under FDA guidance. The company differentiates itself with a science-first approach, a strong track record (97% client satisfaction), and involvement in complex areas like enabling MDMA-assisted therapy research, underscoring a commitment to high-quality, compliant outcomes for sponsors globally.

Company size: 1,001-5,000
Company stage: Not listed
Total funding: Not listed
Headquarters: Canton, Michigan
Founded: 2006

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