Temp - Sr Manager, Vendor Quality, Global Development Quality

Location
Tarrytown, NY, United States
Posted
Apr 22, 2021
Ref
24484BR
Discipline
Quality, Quality Control
Required Education
Associate Degree
Position Type
Contract
The Sr Manager, Vendor Quality will support the Director, Vendor Quality with GCP / GvP / GcLP / GMP quality oversight of vendors used in the conduct of clinical trials, including (but not limited to) CRO, Laboratory, IRT, Imaging, Safety, eCOA, FSP, home health and distribution vendors

We expect this role will support the implementation of Quality Agreements with vendors and will reassess / update these periodically. He/she will support the establishment of a quality oversight framework, lead and/or support Quality Oversight meetings for selected vendors, and serve as a CAPA Lead (oversight) for significant and/or systemic vendor quality issues. This role will also contribute to process improvement initiatives to optimize Regeneron's effective oversight of vendors.

We expect this role will serve in a consultative capacity as a subject matter authority (SME) for matters that impact the vendor's quality and compliance.

We expect this position to operate independently and autonomously, and to serve as a back-up to represent their supervisors and/or other Directors e.g. during meetings / forums.
In this role, a typical day might include the following:

Serves as a Vendor Quality Lead for assigned vendors ensuring effective and collaborative oversight of the relationship as it relates to quality.

Implements, leads and/or supports Vendor Oversight Meetings / Calls with the Vendor counterparts and additional required Regeneron partners.

Ensures evidence of the Quality Oversight framework implemented for assigned vendors is maintained and filed.

Leads successful and collaborative partner relationships with Regeneron Global Development Quality team, Vendor Relationship Management, and other relevant functional Leads / Representatives.

Supports the implementation of Quality Agreements for relevant vendors (including periodic review for suitability and compliance).

Ensures effective customer concern and assessment of significant issues, via the Suspected Serious Non-Compliance (SSN) process, for any issues that potentially represent serious GCP / GvP / GcLP non-compliance or serious breaches.

Provides review, input and approval of any CAPAs associated with GCP / GvP / GcLP non-compliance or audits of those vendors, including serving as the CAPA (Oversight) Lead for any significant / systemic issues attributed to the vendors processes and/or systems.

Establishes reporting and analysis of Key Quality Indicators (KQI) for assigned vendors.

Reviews quality data from Regeneron's electronic Quality Management System (eQMS) to support the analysis, trending and reporting of vendor quality issues and events.

Provides consultation, guidance, training and support to the Regeneron team in respect to compliance with applicable international regulations, practices and guidelines.

Provide and supports process improvement initiatives and work groups relevant to Regeneron's effective oversight of its vendors.

Serves as a back-up to their supervisor and/or other Directors, Vendor Quality (as required).

May be required to support regulatory inspection activities, as required.

Establishes and maintains close working relationships with staff to ensure compliance risks, issues, and breaches are successfully managed and ran to closure.
This role might be for you if:
  • Associates or Bachelors degree with at least 5-8 years of relevant proven experience
  • Detailed knowledge and application of international requirements of Good Clinical Practice (GCP) and ICH E6 R2 Guidelines
  • Experience with Regulatory Inspections (e.g. FDA, EMA, MHRA, etc.)
  • Strong global knowledge and understanding of regulations applicable to the conduct of clinical trials
  • Solid understanding of clinical development and operations
  • Experience in providing training on key quality and regulatory compliance information
  • Self-motivated with the ability to work effectively in a dynamic environment
  • Ability to influence and work with partners at different levels of the organization
  • Strong problem solving, written and verbal communication skills
  • Ability to effectively manage multiple priorities.
  • Attention to detail and accuracy of work.
  • Strong PC literacy required e.g. MSOffice skills (Outlook, Word, Excel, PowerPoint; One Note; Teams); SharePoint


Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.