Temp Global Development Quality Management 

Pay Range: $121.07 - $152.16/hr

Onsite Role in Armonk, NY

12 Month Contract

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 preparation and conduct of Regeneron-sponsored clinical trials from the time of synopsis generation and protocol authoring through final CSR. 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 direct risk-based quality management activities on all Regeneron-sponsored clinical trials, inclusive of issue management and ensuring clinical study team inspection readiness. The GDQM (GCP) QML will partner with other members of the GDQM (GCP) team to identify trends through metrics in order to diagnose and remediate systemic quality issues.

In this role, a typical day might include the following:

Providing oversight, direction, guidance, and mentoring (team members at all levels) to assist individuals with the planning and prioritization of tasks and activities.

Leading quality-related and/or cross-functional process improvement initiatives and work groups, or quality system/technology or automation solutions, as assigned.

Escalating to senior management where further consultation may be required for complex/strategic issues.

Serving as a Subject Matter Expert (SME) in relation to a specific area, process, or system; contributing to procedural document drafting, revision, approvals, and review/approval of process deviations (as relates to their relevant subject matter).

Reviewing and contributing to dedicated quality meetings (e.g., GD Quality Oversight Committee) and multi-disciplinary meetings by sharing cross-functional skills and knowledge

This role may be for you if have experience:

Expert knowledge, understanding and application of GCP, and/or GVP guidelines including the management of significant/complex quality issues and compliance activities.

Expert knowledge, understanding and application of proactive quality management, risk assessment/management, in addition to providing GCP consultancy and support to internal and external stakeholders.

Effective management of interpersonal relationships, stakeholder engagement, collaboration, and negotiation of complex situations issues.

Demonstrated ability to interface and collaborate effectively with other Directors and Leaders within, and external to, the organization.

To be considered for this opportunity, you are expected to have:

Bachelor's degree with a minimum of 12 years of relevant healthcare/pharmaceutical industry experience. Master's degree may be beneficial.

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) regulations.

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints.  Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.  We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third party solicitation