Temp Global Development Quality Management (GCP)

Job description

Job Title: Temp - Global Development Quality Management (GCP)
Location: Armonk , NY
Type: Contract
Compensation: $76 - $76 hourly
Contractor Work Model: Onsite
Duration: 12 months

Leading Pharmaceutical Company located in NJ is hiring a Global Development Quality Management (GCP) w/ 8+ years industry experience.

If you want to be a part of this groundbreaking work, please apply!


The Temp, Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide guidance and leadership for all aspects of quality and compliance within Global Development Quality (GDQ) systems.

The GDQM (GCP) QML will engage with key stakeholders, build strategic partnerships working and liaising with study teams, relevant functions and other GDQ functions to lead risk-based quality management activities on all Regeneron-sponsored clinical trials, inclusive of issue management and providing continuous support of inspection readiness.

In this role, a typical day might include the following:
• Acting as a Subject Matter Expert (SME) and key liaison to GDQ to provide support and advise on any quality issues to ensure compliance and for the Quality Risk Assessment process.
• Ensuring and responsible for Risk-Based Quality Management (RBQM) initiatives and process improvements, in partnership with other functional areas.
• Responsible for the management of GCP-compliant activities from a quality perspective in conjunction with the business and the GDQM (GCP) team.
• Providing day-to-day quality and compliance support to cross-functional stakeholders, including issue management (triage/investigation/actions), audit responses, proactive quality management, Corrective Action/Preventive Action (CAPA) oversight, audit/issue trending.
• Leading Quality Risk Management activities on all Regeneron-sponsored clinical trials within assigned studies.
• Leading Quality Risk Assessment and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICH E6 R2.

This role may be for you if have experience:
• Advanced knowledge, understanding and application of GCP guidelines including the management of significant/complex quality issues and compliance activities.
• Advanced knowledge, understanding and application of proactive quality management, risk assessment/management, in addition to providing GCP consultancy and support to internal and external stakeholders.
• Advanced knowledge and application of risk-based approaches to quality management and oversight, building fit-for-purpose quality processes in partnership with cross-functional teams and leaders.
• Experience with participating in, and managing Regulatory Agency Inspections, in addition to serving as a Subject Matter Expert.

To be considered for this opportunity, you are expected to have:
• Bachelor's degree with a minimum of 8 years of relevant healthcare/pharmaceutical industry experience.
• Experience working in either a quality/compliance role (e.g., Quality Management, Quality Assurance etc.), or in a Clinical Development role with expertise and/or transferable skills related to Good Clinical Practice (GCP), and/or Good Pharmacovigilance Practice (GVP).

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.

We help clients get work done more efficiently and economically, without compromising quality.

System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.



System One is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.



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Ref: #568-Clinical


System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America.

We help clients get work done more efficiently and economically, without compromising quality.

System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Required Skill Profession

Other General