Company Overview

ConcertAI?s mission is to accelerate insights, advance research, and improve patient outcomes in oncology and across life sciences. ConcertAI?s leading real-world evidence, AI technology and software-as-a-service solutions support healthcare decision-making across clinical research & development through commercialization. Top biopharma sponsors, clinical research organizations, healthcare providers and institutions rely on ConcertAI?s evidence-generation and digital transformation capabilities to advance precision medicine and medical innovation.

Role Summary

The Software Quality Assurance Manager is responsible for oversight of the team supporting quality control throughout the development of multiple software organizational data products and clinical development technologies. The Manager is responsible for scoping and delegating the work associated with validation documentation, UAT, developing and executing on a testing strategy, performing validation activities, and authoring validation deliverables. The incumbent will be responsible for designing and conducting software tests and continuing to develop and mature the company?s validation practices. The Senior Software Quality Assurance Manager must be able to manage competing priorities, simultaneous multiple validation activities while and ensuring the highest quality testing and validation practices and deliverables. The individual will manage an expanding team of software QA specialists and is responsible for providing all required support of completed validation documentations in internal and external audits and/or inspections. This role is for an experienced SQA professional and will act as a leader with responsibilities for ensuring quality and mentorship of junior SQA staff.

Responsibilities

• Lead a growing team of software QA specialists by scoping and assessing the needs of multiple data products, planning and delegating the work for completion to required timelines.
• Provide software QA SME in all required audits and inspections, ensuring organizational compliance and successful audit completion.
• Determine timelines and lead project management activities associated to developing standard and release-specific test scripts, validation of requirements and completion of testing and validation deliverables with minimal supervision.
• Provide supervision and mentorship to junior SQA staff
• Act as responsible SME to provide expertise on experience with validation / compliance practices and have worked with multiple types of software, and testing vendors.
• Responsible for deliverables, leading and oversight of all 21 CFR and GxP validation packages for product/development teams across the organization, review and approve all the validation artifacts.
• Responsible for deliverables, leading and oversight, development + approval of the test packages and facilitate UAT (User acceptance testing) with client teams.
• Responsible for solutioning and resolving issues with software validation activities and conveying escalations to leadership or other department members in a timely manner, requiring excellent written and verbal communication skills
• Primary POC and SME during internal and external audits.
• Develop creative solutions for complex software and business issues and apply these solutions to resolve problems
• Manage multiple projects and competing priorities under strict timelines.

Requirements

• Bachelors degree required
• Minimum 5-7 years? experience performing software validation on major system releases
• Advanced knowledge of 21 CFR Part 11 compliance is required
• Compliance, and additional validation guidelines are mandatory for success in this role
• Must be organized, detail-oriented, and able to coordinate multiple projects with shifting priorities
• Must be able to work independently and as a part of a team
• Demonstrates the tenacity to learn and adapt quickly
• Has a strong work ethic and is comfortable under the pressure of tight deadlines
• Strong proficiency in the entire Microsoft Office Suite

Learn More About ConcertAI

Our team at ConcertAI is dedicated to transforming healthcare decision-making through the application of RWE and AI to improve patient outcomes. We work in a fast-paced, dynamic, high-performing culture where diversity, collaboration, and innovation are valued. Join us on our quest to create a world free of disease. Learn more about ConcertAI at www.concertai.com , or follow us on LinkedIn.

EEO

ConcertAI provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.