QA Software Testing Manager

About the Role

Medpace Clinical Research India is expanding its corporate operations and is seeking a full-time Software Testing Manager to join its Information Technology department based in Navi Mumbai. The role entails leading a team of software testing engineers and overseeing software validation initiatives to ensure the delivery of robust and high-quality software solutions.

Company Overview

Medpace is a comprehensive clinical contract research organization serving the biotechnology, pharmaceutical, and medical device sectors. It offers clinical development services spanning Phases I-IV with expertise across multiple therapeutic areas including oncology, cardiology, metabolic diseases, and more. Headquartered in Cincinnati, Ohio, Medpace employs over 6,000 professionals across 40 countries globally to accelerate the development of safe and effective medical treatments through a rigorous scientific approach.

Key Responsibilities

• Lead and coordinate validation staff in creating and maintaining Software Development Life Cycle (SDLC) validation deliverables for regulated software applications, including validation and test plans, user requirements specifications, testing documentation, traceability matrices, and validation summary reports.
• Assign and prioritize systems and projects for validation team members based on project deadlines and resource availability.
• Oversee change control management for company software applications to ensure smooth transitions and updates.
• Ensure that Medpace computer systems comply with regulatory standards including GxP and SOx requirements.
• Maintain and update system validation Standard Operating Procedures (SOPs) to align with regulatory mandates and industry best practices.
• Guide the validation team in adopting tools and procedures that streamline validation and documentation processes.
• Participate actively in audits conducted by sponsors to demonstrate compliance and quality standards.

Candidate Qualifications

• Bachelor's degree from an accredited institution.
• Minimum 7 years’ experience in software development life cycles, testing, and validation, with preference for candidates familiar with Agile methodologies and regulated industries.
• Advanced understanding of SDLC processes and risk management applications.
• Proficient analytical, oral, and written communication skills in English.
• Previous leadership experience supervising teams is preferred.
• Experience in regulated healthcare environments with knowledge of Good Clinical Practice and 21 CFR Part 11 is advantageous.

Additional Information

Medpace has positively influenced patients' lives for over three decades by providing clinical research across critical therapeutic fields. The company offers a variety of employee benefits and a culture focused on professional growth and work-life balance.

Employee Benefits

• Flexible working environment accommodating diverse needs.
• Competitive salary accompanied by a comprehensive benefits package.
• Generous paid time off policies.
• Clearly defined career development paths fostering professional growth.
• Company-organized appreciation events to recognize employee contributions.
• Health and wellness programs designed to support employee well-being.

Recognitions

• Awarded by Forbes as one of America’s Most Successful Midsize Companies consecutively from 2021 to 2024.
• Received continuous accolades from Life Science Leader magazine for CRO leadership in expertise, quality, reliability, and compatibility.

Next Steps

A representative from Medpace will evaluate applications and contact qualified candidates to provide information regarding further stages of the recruitment process.