Within this role you will be responsible for the management and leadership of the Quality Assurance Operations function. This role will be part of the QA Operations site management team and is a key leader in the cross functional support of the manufacturing activities. This role will proactively identify and implement industry best practices for cGMP across manufacturing, quality control, materials management, and validation.
As an Associate Director in QA Operations, a typical day might include, but is not limited to, the following:
- Overseeing QA Operations, processes and directing the activities of the QA Operations management team
- Owning and continuously improving the batch review activities to support batch disposition of Regeneron Products
- Overseeing Ireland Document Control (DC) operations and directing the activities of the DC management team
- Ensuring alignment is maintained and achieved across the manufacturing sites for areas of responsibility
- Providing technical expertise and leadership with respect to cGMP across manufacturing, quality systems, investigations, batch review, product technical transfer, and other areas, as required
- Interacting with critical biotechnology commercial and clinical API manufacturing operations, facilities to ensure a successful compliance profile
- Defining and implementing quality standards, systems, and metrics for commercial and clinical operations
- Ensuring that products adhere to tight internal standards as well as those of the agencies that regulate the pharmaceutical industry around the world
- Involving in aspects of Regulatory Agency interactions and preparation as related to site inspections, and ensures regulatory observations are adequately addresses and completed on schedule
- Partners with critical contract manufacturers to resolve compliance issues in commercial and clinical supply chains, interfaces with customer/partner quality organizations, and negotiates third party contractor and supplier quality agreements
- Authorizing significant deviations to established, approved procedures, provides guidance to assist co-workers with troubleshooting investigations and problem resolution
- Ensuring safety and operational standards are maintained
To be considered for this opportunity you should have a BS or higher in life sciences and a minimum of 14+ years of related experience in the pharmaceutical/biotechnology industry.
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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.