Quality Specialist - Legal; Risk & Compliance

 Are you ready for the Most Impactful Work of Your Life?
Working at Signant Health puts you at the very heart of the world’s most exciting sector - a high-growth, dynamic company in an extraordinary industry. We’re radically changing the clinical trial landscape, driving change through the technology and innovations we create and the services we deliver to our customers.

Where do you fit in?

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We're on the hunt for a new Quality Specialist who will be responsible to perform independent quality review and approval of computerized system validation (CSV) documentation related to products, client projects and clinical studies or enterprise systems to ensure adherence with internal processes and GxP regulations, as applicable. The role will also support managing compliance aspects of the organization’s computerized systems and services.
Want to join the Best Team of Your Life?
We’re looking for people who are excited by the potential to make a difference in the world. You don’t need to have a clinical background to thrive at Signant. You need to be decisive, open to celebrating mistakes, able to communicate transparently and inclusively, and someone your team can count on. Most of all you need to be yourself!

As part of our team, your main responsibilities will be:

• Providing subject matter expertise for processes which contribute to the quality of work for projects and products used in support of GxP regulated activities.
• Supporting CAPA (Corrective and Preventive Actions), Quality Management Reviews, and Quality Audit activities.
• Identifying non-conformances to requirements, seeking suitable recommendations and supporting ongoing quality improvements using a risk-based methodology.
• Assisting in maintaining the organization’s compliance with applicable study protocols, regulations, and standards where applicable.
• Identifying and escalating quality events/issues, and client complaints.
• Supporting implementation of methodology for specific quality/product compliance issues with accountability to ensure appropriate and timely mitigation and resolution.
• Supporting and ensuring current quality processes and industry best practices are in place to manage interdisciplinary issues across the company with the goal to establish a more efficient and effective standardized approach(s).
• Reviewing internal policies to assure systems compliance; and consults on development of quality improvements.
• Regularly raising quality and compliance challenges and assisting team members with resolution.
• Supporting internal/external audits and inspections.
• Providing subject matter expertise and assisting with training stakeholders.

You’ll need to bring:

• Associates degree or equivalent of 2 years of college required;
• At least three (3) years of GxP experience;
• Experience with current industry guidance and best practices related to software development, system, study, and data life cycles (GAMP, CSV, CSA, QbD, DibD);
• General understanding of GxP compliance requirements related to computerized systems, eClinical platforms, and SaMD (e.g., FDA 21 CFR Parts 11 and 820, EudraLex Volume 4 and applicable annexes; as well as ICH and ISO standards);
• Strong organizational, time-management, analytical and decision-making skills;
• Ability to work independently and accomplish work goals in a fast-paced and challenging work environment;
• Ability and willingness to travel domestically and internationally as required;
• Ability and willingness to work non-standard business hours as business needs dictate;
• Bachelor’s degree in engineering, information systems, business, or computer science;
• Good practical testing skills and an understanding of the QA and development processes;
• Good analytical skills with a proven ability to comprehend business requirements;
• Practical experience with any modern test management, defect tracking, and requirement tools;
• Ability to work in a team-oriented environment, providing backup support to team members;
• Strong skills with Microsoft Office applications;
• Must be a team-oriented person with a “can-do” attitude.

And finally, here are the ways of working that will help you succeed at Signant:

• You enjoy problem-solving and have a constructive can-do attitude.
• You’re motivated by working in a fast-growing global company.
• You’re self-driven, active and want to continuously learn new things.
• You have great communication skills in English, both spoken and written, and can articulate technical details succinctly.
• You like to share knowledge as a way to advance organisational learning.

Does this sound like something you’d like to explore? Then we’d love to hear from you!

Please apply below. We review and respond to every application, keep an eye on your inbox for our reply.

Please note that Signant does not accept unsolicited resumes from Third Party vendors.
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At Signant Health, accepting difference isn’t enough—we celebrate it, we support it, and we nurture it for the benefit of our team members, our clients and our community. Signant Health is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.

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