Product Leader – Quality & Compliance Software

Published
October 29, 2021
Location
Telecommute, Canada
Category
Job Type
Experience
Director

Description

Xybion is a leading software, services, and consulting company dedicated to helping corporations solve business problems. Through intelligently designed systems and business processes, we help companies become more efficient, reduce costs and manage compliance, regulatory adherence and risk. Serving more than 150 customers in 16 countries. Xybion has the global scale and expertise to bring employees around the world together to manage complex business processes and improve program administration.

Our unique solutions focus on integrated preclinical lab management, early-stage drug discovery, employee health & safety, quality management, regulatory compliance, GLP, content migration and systems validation. Since its founding in 1977, Xybion Corporation has supported, through software, services and consulting, 100% of the top 20 global life sciences companies.

Product leader / SME – Compliance, Quality & Risk Management

At this time, we are rapidly expanding our Canadian presence, currently searching for a number of technical resources, including a CQRM Subject Matter Expert.

In this role you'll help develop and implement software product for our clients in the Pharmaceutical Discovery & Preclinical Development research domain. You’ll work with clients to understand their challenges and determine their requirements, and you'll support your software development colleagues in developing, refining and maturing our software products.

You can work remotely, collaborating with colleagues at our Quebec City office and elsewhere.

As an ideal candidate, you bring deep expertise in quality audits, non-conformance, and compliance processes. You’ve had exposure to software product development or implementation. You’re technologically savvy, with outstanding client-facing skills and the drive to identify and solve problems. And like us, you’re collaborative, entrepreneurial, Agile, fast-moving, and innovative.

Key Responsibilities

  • Provide quality and compliance subject matter expertise to our customers, including pharmaceutical companies, CROs, and other research institutions and facilities, enabling them to streamline and automate their operations through software-driven solutions.
  • Review Xybion software products in the CQRM space and help improve the product functionalities.
  • Work with Xybion product teams to develop CQRM software products.
  • Work with clients to run workshops and develop an understanding of requirements.
  • Advise on best practices, industry issues and client-specific challenges.
  • Provide thought leadership and other consultancy services in the quality and compliance domain.
  • Monitor and review our software products and help improve product functionality.
  • Maintain high client satisfaction by providing proactive communication and issue management.
  • Work with global clients and global Xybion teams.

Essential Qualifications

  • 8+ years of relevant experience.
  • Significant knowledge of internal/external quality audits, CAPA, Non-conformance/OOS.
  • Considerable experience with Quality Management Systems (QMS).
  • Thorough understanding of Life Sciences regulations.
  • Strong understanding of the pharmaceutical industry and Good Laboratory Practice (GLP).
  • Skilled in presenting scientific and technical information.
  • Skilled in client management, business analysis and requirements gathering.
  • Knowledge of, and exposure to, domain software systems and tools.
  • Highly organized, with exceptional communication skills and attention to detail.
  • A natural problem-solver; driven; quick to learn.
  • Positive, collaborative and constructive – a true team player.

Compensation

We offer highly competitive compensation, including a performance-linked bonus, along with a comprehensive benefits package.

To Apply

Interested applicants can prepare their resume and cover letter and submit them here.

We thank all applicants for their interest; however, only those selected for an interview will be contacted. For more information about Xybion, please visit https://www.xybion.com/.

Xybion respects the dignity and independence of people with disabilities, and is committed to providing accommodation and support to persons with disabilities throughout the recruitment and selection process. If you require accommodation or support, please indicate so in your application.

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