Job Description
The Associate Manager, Global Development Quality Technology & Compliance (GDQTC) will provide support to the GDQTC team with activities related to the maintenance and support of the Quality Vault and/or Computer System Validation (CSV), as assigned. We expect this GDQTC professional will also support general administrative duties to assist with the effective management of departmental activities, as assigned.
In this role, a typical day might include the following:
- Leading the review of CSV items, such as Validation Plans, Requirements, Specifications, Test Protocols/Plans, Summary Reports, Traceability Matrix, etc. for adherence to internal policies and standards.
- Responsible for the development and maintenance of CSV policies and procedures by interpreting regulations, guidance, and current industry standard processes.
- Supporting the performance of periodic evaluations on computer systems and equipment including the identification of any potential compliance and data integrity gaps.
- Developing the review and approval of equipment qualification artifacts, such as Equipment Change Controls, Qualification Protocols and Qualification Summary Reports.
- Creating the analysis of results from testing and the acceptability of results against predetermined criteria.
This role might be for you if:
- You are a quality trained professional with a focus in CSV and/or IT related projects
- You are able to handle ambiguity well and can take action with minimal guidance
- You can navigate a global environment and communicate across different teams across the globe
To be considered, we are looking for individuals who have a bachelor's degree at minimum and with +4years of experience in the Quality space. We are open to considering Sr. Specialist at this time as well. We would require this individual to be in the office a couple days a week.
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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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)