Medpace

QA Software Testing Manager

Medpace$90K — $120K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree required
  • 7+ years in SDLC, testing, and validation, ideally in Agile and regulated sectors
  • Advanced knowledge of software development life cycle
  • Understanding of Risk Management concepts
  • Strong analytical, written, and oral communication skills
  • Preferred supervisory experience
  • Experience in regulated healthcare industry is a plus, including knowledge of Good Clinical Practice and 21 CFR Part 11

Responsibilities

  • Lead the validation team in creating and maintaining SDLC validation deliverables for software applications
  • Assign validation tasks based on project priorities and team availability
  • Oversee validation staff in managing software change control
  • Ensure compliance with GxP and SOx for computer systems
  • Maintain validation SOPs in accordance with regulatory standards
  • Align validation SOPs with industry best practices
  • Implement tools and procedures for efficient validation and documentation
  • Participate in Sponsor audits

Benefits

  • Flexible work environment
  • Starting at 20+ days of PTO
  • Company-sponsored employee appreciation events
  • Employee health and wellness initiatives
  • Discounted tuition for UC online programs
Full Job Description
Job Summary

Our corporate activities are growing rapidly, and we are currently seeking a full-time Software Testing Manager to join our Information Technology team. This position will manage a team of software testing engineers and software validation projects to implement effective and high quality software solutions. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you!

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;
  • 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!


What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

About Medpace

Medpace is a clinical research organization that provides services to pharmaceutical, biotechnology, and medical device companies. The company's services include clinical trial management, regulatory consulting, and medical imaging. Medpace was founded in 1992 and is headquartered in Cincinnati, Ohio. The company has operations in North America, Europe, and Asia.
Learn more about Medpace
Size
4,700 employees
Market Cap
$6.4 billion
Industry
Net Income
$145.3 million
Founded
1992
5 Year Trend
+22.1%
Revenue
$925.9 million
NASDAQ

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