Job Description
The successful candidate will be responsible for the management and leadership of the Quality Systems Operation function. As part of the QA Operations Site Management Team you will be a key leader in the cross functional support of cGMP compliance activities and will be immersed in Quality Systems for the site to identify potential risks and trends and to support during regulatory inspections and internal audits. This role will provide Quality and Compliance oversight across manufacturing, quality control, quality assurance, technical operations, materials management, and validation. As the Associate Director Quality Systems, a typical day might include, but is not limited to, the following: Overseeing Quality Systems Operations, processing and directing the activities of the Quality Systems management team Owning and continuously improving the Quality Management Systems including but not limited to deviations, CAPAs and change controls Providing technical guidance and building technical capability within the team Ensuring compliance with all aspects of quality for the site inclusive of manufacturing, quality systems, quality control, validation, technical operations, and materials management Ensuring alignment is maintained and achieved across the manufacturing sites for areas of responsibility Providing technical expertise and leadership with respect to cGMP across the site, quality systems, investigations, changes, and other areas, as required Interacting with critical biotechnology commercial API manufacturing operations facilities to ensure a successful compliance profile Defining and implementing quality standards, systems, and metrics Ensuring that products adhere to tight internal standards as well as those of the agencies that regulate the pharmaceutical industry around the world Supporting in aspects of Regulatory Agency interactions and preparation as related to site inspections, and ensures regulatory observations are adequately addressed and completed on schedule Partnering 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, providing guidance to assist co-workers with troubleshooting investigations and problem resolution Ensuring safety and operational standards are maintained This role might be for you if you: Maintain integrity and honesty at all times Communicate with transparency Have a strong background and are familiar with site change control, risk management and data integrity initiatives/programs Are a passionate leader who can drive and motivate employees Continuously drive processes for improved performance To be considered for this position you must hold a BS or higher in life sciences with 10+ years of relevant experience in QA within the Pharma / Biopharma Industry. You must have at least 5 years of people management experience. 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. 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.