QA Software Testing Manager at Medpace, Inc.

Navi Mumbai, maharashtra, India -

Full Time

Start Date

Immediate

Expiry Date

13 Sep, 26

Salary

0.0

Posted On

15 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Software Testing Management, SDLC, Validation Planning, User Acceptance Testing, Traceability Matrices, GxP Compliance, SOx Compliance, Agile Methodology, Risk Management, Supervisory Experience, Good Clinical Practice, 21 CFR Part 11, Analytical Skills, Written Communication, Oral Communication, Change Control

Industry

Pharmaceutical Manufacturing

Description

Our corporate activities are growing rapidly, and we are currently seeking a full-time Software Testing Manager to join our Information Technology team in Mumbai. This position will manage a team of software testing engineers and software validation projects to implement effective and high quality software solutions. Responsibilities Lead validation staff in developing, coordinating, and maintaining full SDLC validation deliverables for Medpace regulated software applications, including Validation & Test Plans, User Requirements & Functional Specifications, Functional & User Acceptance Testing, Traceability Matrices, and Validation Summary Reports; Coordinate and assign systems and projects to validation staff according to priorities, timelines and availability; Maintain oversight of validation staff in managing change control of Medpace software applications; Ensure compliance of Medpace computer systems with GxP and SOx regulatory requirements; Ensure compliance of system validation Standard Operating Procedures (SOPs) with regulatory requirements; Ensure consistency of systems validation SOPs with best practices of industry; Lead validation team in implementing tools and procedures to facilitate validation and documentation activities; and Participate in Sponsor audits. Qualifications Bachelor's Degree; 7+ years of experience in SDLC, testing, and validation, preferably in an Agile environment and/or regulated industry; Advanced knowledge of software development life cycle; Knowledge and understanding of the application of Risk Management concepts; Excellent analytical, written, and oral communication skills in English; Previous supervisory experience is preferred; and Experience in the regulated healthcare industry, with working knowledge of Good Clinical Practice and 21 CFR Part 11, is a plus! Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Responsibilities

Lead a team of software testing engineers to develop and maintain SDLC validation deliverables for regulated software applications. Ensure all systems comply with GxP and SOx regulatory requirements while managing project priorities and timelines.