The Quality Assurance Manager will perform GQP duties related to the distribution and launch of pharmaceutical products under the Associate Director of Quality Operations (Hinseki). This role will work under the direction of the Associate Director to perform the implementation and will work with Regeneron global folks to execute of the Regeneron Quality Management System relating to good distribution practices (GDP) and product release.
There will be significant engagement and collaboration with Global IOPS (Industrial Operations and Product Supply) teams. In accordance with the GQP General Rules for Quality Assurance Operations, you may be asked to act as a substitute in the absence of Hinseki. Responsibilities will include, but are not limited to, the following :
GQP & GMP Quality Assurance
• Quality Management: GQP QA Release, Inspection, Change Control, Deviation • Creation and maintenance of Quality Agreement for Supplier
• Correspondence of the quality complaint, execute the quality improvement program
• Document Control and management of Global SOPs and related documents
• Correspondence with PMDA and Tokyo Metropolitan office (including Inspection)
• Investigate causes of quality defects and follow up on CAPAs
• Training for QA members and GQP self-Inspection
• Introduction and maintenance of Quality Systems (Document Management system) including CSV and ER/ES GQP/GMP（SOP） • Others quality assurance related tasks
Requirements
• Bachelors degree in scientific discipline; Advanced scientific degree preferred
• It is desirable to have a pharmacist license
• At least 7 year experience in pharmaceutical industry GMP/GQP as a QA Manager
• Expertise and skills in all areas of quality assurance, quality control, manufacturing control, and CMC regulatory , who are able to perform work independently. (e.g.: Primary response when obtaining quality information from manufacturers, knowledge of MRA/MOU, etc.)
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.
