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Quality Specialist - Legal; Risk & Compliance

Signant Health

Signant Health

Legal, Quality Assurance
Remote
Posted on Tuesday, May 28, 2024

Quality Specialist - Legal; Risk & Compliance

Remote - RO, Remote - RO, Iași, Romania Req #2769
Tuesday, May 28, 2024

Quality Specialist - remote, Romania

This is a fixed term contract - for 2 years.

This could be the Opportunity 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?

We're on the hunt for a new Quality Specialist for one of our teams in Romania working on the Compliance and Quality Management area.

The Quality Specialist is responsible to perform independent quality review and approval of computerized system validation (CSV) documentation related to products, client projects and clinical studies (e.g., IRT, IxRS/IvRS, EDC, ePRO/eCOA, eCRF), or enterprise systems to ensure adherence with internal processes and GxP regulations, as applicable. The role also supports 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 to:

  • Provides subject matter expertise for processes which contribute to the quality of work for projects and products used in support of GxP regulated activities.
  • Supports CAPA (Corrective and Preventive Actions), Quality Management Reviews, and Quality Audit activities.
  • Identifies non-conformances to requirements, seeks suitable recommendations and supports ongoing quality improvements using a risk-based methodology.
  • Assists in maintaining the organization’s compliance with applicable study protocols, regulations, and standards where applicable.
  • Identifies and escalates quality events/issues, and client complaints.
  • Supports implementation of methodology for specific quality/product compliance issues with accountability to ensure appropriate and timely mitigation and resolution.
  • Supports 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).
  • Reviews internal policies to assure systems compliance; and consults on development of quality improvements.
  • Regularly raises quality and compliance challenges and assists team members with resolution.
  • Supports internal/external audits and inspections.
  • Provides subject matter expertise and assist 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.
  • preferred.

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!

To apply, please submit your CV and a cover letter letting us know why you think you’d be perfect for this role.

We will begin reviewing submissions during the application period and will fill the vacancy as soon as a suitable candidate is identified.

Please note that Signant does not accept unsolicited resumes from Third Party vendors.

#LI-RM1 #remote

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.

Other details

  • Job Family Legal; Risk & Compliance
  • Job Function ALG-Regulatory Compliance Law
  • Pay Type Salary