The External Filling QA team is hiring an Associate Manager/Manager QA. This position provides leadership and support to direct reports and reviews/approves various documentation related to the External Filling function.
In this role, a typical day may include the following tasks
Responsible for all aspects of QA Team including review and approval of the following types of documents, relating to area functions: Master records, Executed records, Failure investigations, CC, SOPs, and Validation protocols and summary reports
Approves various documents relating to area function, including those listed above.
Organizes QA resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management.
Performs compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
Reviews customer requirements and implements required processes, as needed, to meet customer expectations regarding Quality.
Participates in regulatory and customer audits.
To be considered for this role, you must hold a BS/BA in life sciences discipline or related field (chemistry, biology, or pharmacy require and the following amount of relevant experience for each level:
- Associate Manager: 6+ years
- Manager: 7+ years
Experience in Pharmaceutical Biologics, or Gene Therapy (e.g., AAV, VLP, siRNA) Manufacturing Environment preferred
May consider equivalent combination of education and experience. Level to be determined based on qualifications relevant to the role.
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)