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

This position is responsible for conducting risk-based technology audits with GCP auditor including, but not limited to, product development audits, computerized system audits, vendor qualifications/audits to confirm compliance with quality assurance standards and regulations. The candidate will also be responsible for leading efforts to implement electronic quality management system (eQMS) components and serve as inhouse eQMS expert of audit component.

Responsibilities

• Create a risk-based audit plans for various complex internal and external[PP1] processes and products with ConcertAI audit team members
• Ensuring that audits are conducted as per the audit plan, audit schedule and reports prepared are honest, accurate, impartial, and useful.
• Opening and closing an audit meeting and assisting with follow up audit.
• Confirming CAPA effectiveness and closing out audits
• Building great relationships, learn about business and products and allowing them to achieve the state of enhanced and sustainable Information Resilience.
• Proactively recognize areas of improvements
• Conducts/Coordinates routine and ad-hoc mock inspections / rehearsals
• Provide support for regulatory inspections and sponsor audits
• Responsible leading efforts to implement electronic quality management system (eQMS) components and serve as inhouse eQMS expert
• Establish and utilize eQMS in support of Audit lifecycle
• Support QA team in promotion and assessment of compliance to regulations, guidelines and corporate policies, lead/support in QA initiatives/projects for quality, process improvements

Keys to success in this job:

• Key auditor traits: professional, ethical, open-minded, diplomatic, observant, perceptive, versatile, tenacious, decisive, self-reliant, collaborative, culturally sensitive, acting with fortitude, open to improvement.
• Risk based thinking and process approach as well as synthesizing information to prepare summary reports.

Requirements

• Bachelor’s degree education.
• At least 4 years’ industry experience in Information Technology (IT)/ Information Security (IS)
• 2 years experience in Pharma, specifically GCP
• Experience in auditing IT Infrastructure, prior IT audit experience is must
• Advantageous to be certified Information Security Auditor (such as, CISA)
• Demonstrates a fundamental knowledge of current relevant GXP regulations, guidelines, and related auditing techniques
• Highly proficient with MS Office, project management software.
• Effective problem-solving skills with a demonstrated ability to identify and quickly resolve issues.
• Excellent written and verbal communication and presentation.
• Able to work successfully in a diverse team environment.

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 onLinkedIn.

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.