CMC Product Quality Compliance Specialist (Distribution Compliance) - BioSpace : Job Details

Job DetailsThe CMC Product Quality Compliance Clinical Distribution team is hiring! The QA Associate Specialist supports QP certification activities with the ultimate goal of supplying EU and UK clinical studies. This position works closely with regulatory, clinical distribution supply logistics, supply planning teams, and contract manufacturing organization Qualified Persons.In this role, a typical day may include:

• Working collaboratively with CMC team members, regulatory, quality, and supply planning cross-functional teams to ensure continuity of clinical supply
• Supporting distribution compliance through obtaining appropriate GMP source documentation and ensuring compliance to GMP and approved regulatory filings
• Compilation of a documentation package to support QP certification
• Review, edit, approve or coordinate workflow of Regeneron controlled documents
• Responding to queries from QPs or cross-functional teams to support timely QP certification and supply of clinical studies
• Coordination of document completion across cross-funcational teams in preparation for regulatory submissions
• Continually evaluating Regeneron processes and procedures with a focus on quality, compliance, and continuous improvement

This role may be the right fit for you if you:

• Good organizational skills and attention to detail
• Requires excellent written, verbal, and interpersonal skills and the ability to effectively interact cross-functionally
• Ability to handle multiple assignments and changing priorities
• Ability to learn and use computerized systems for performance of daily tasks
• Ability to prioritize across multiple tasks, and meet deadlines

To be considered for this role, you must hold a Bachelors degree in Chemistry, Biology, or related field, with relevant experience or equivalent combination of education and experience for each level:

• Assoc. CMC Product Quality Compliance Specialist: 0-2 years
• CMC Product Quality Compliance Specialist: 2+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.#REGNQADoes 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)$59,700.00 - $108,400.00