The QA Oversight department at Regeneron is adding to their team. The QA Oversight Specialist - External Partners coordinates the equipment, systems, and processes validation for our CMO and partner groups in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.
In this role, a typical day many include:
Responsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions.
Presents project and program status and metrics to Senior Management. Act as Technical Subject Matter Expert (SME) in at least one area (e.g. Equipment Qualification, DP Filling Validation, Assembly Validation, LDP Label/Pack Validation, CN/PN Change Control)
Must be able to present in a pressure test scenario the technical area they are SME for
Stays current with industry trends, regulatory requirement updates, and motivates changes and improvements based on trends.
Generates, implements and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
Reviews, edits and approves change controls, SOPs, reports and other documentation
Coordinates with other departments or outside contractors/vendors to complete validation tasks.
Collaborates with functional departments to resolve issues.
Trains/advises less experienced Specialists.
Manage and drives projects and prepares status reports.
May present at both internal and external (regulatory) audits
Stays current with industry trends, regulatory requirement updates, and communicating same to team
May manage full time employees and/or contingent workers.
Performs other duties assigned by Management.
Some travel may be required (approximately 25%)
This role may be a fit for you if you:
Drug product filling, assembly qualification and pack & label experience is helpful
Ability to maintain integrity and honesty, while communicating with transparency
Continuously aim to improve processes for improved performance
Demonstrate supportive behavior at all times
Accountable for technical performance and results of team
Manage internal and external relationships
Develop strategy and create metrics to measure effectiveness of strategy
To be considered for this role, you must hold a Bachelors degree in Engineering, Chemistry, or Life Sciences and the following minimum amounts of experience required for each level:
May substitute proven experience for education requirement.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$58,480.40 - $106,300.00