Quality Specialist - Legal; Risk & Compliance
Signant Health
Fecha: hace 3 días
ciudad: Santiago, Región Metropolitana
Tipo de contrato: Tiempo completo
Are you ready for the Most Impactful Work of Your Life?
Signant Health is a global evidence generation company. We’re helping our customers digitally enable their clinical trial programs, meeting patients where they are, driving change through technology and innovations and reimagining the path to proof.
Working at Signant Health puts you in the very heart of the world’s most exciting sector - a high-growth, dynamic company in an extraordinary industry.
Where do you fit in?
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:
Language: Resumes must be submitted in English.
Ready to join the adventure? Apply now and be a part of Signant Health’s exciting journey!
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.
Signant Health is a global evidence generation company. We’re helping our customers digitally enable their clinical trial programs, meeting patients where they are, driving change through technology and innovations and reimagining the path to proof.
Working at Signant Health puts you in the very heart of the world’s most exciting sector - a high-growth, dynamic company in an extraordinary industry.
Where do you fit in?
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:
- 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.
- Interacts with cross-functional team members to support effective relationships with other teams.
- Cross-trains Quality team members, provides constructive feedback and suggestions for improvement.
- Fosters effective and open interdepartmental communication and cooperation.
- 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 preferred
Language: Resumes must be submitted in English.
Ready to join the adventure? Apply now and be a part of Signant Health’s exciting journey!
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.