Principal Quality Systems Specialist

The Quality System Specialist participates in maintaining site compliance of operations in accordance with mandated regulatory requirements and site expectations. The Quality Systems Specialist provides oversight of the Quality Management System (QMS) implementation and use. This position may also support global elements of the QMS and lead or participate in continual improvement initiatives.

A typical day might include, but is not limited to, the following: 

• Being responsible for ensuring compliance with all aspects of quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management

• Maintaining regulatory compliance in accordance with current Good Manufacturing Practices (cGMP)

• Collaborating with cross functional teams in resolving issues, completing investigations and maintaining compliance

• Being responsible for QA reviewing and approving of the following types of documents: Failure Investigations, Corrective and Preventative Actions (CAPA), Standard Operating Procedures (SOP’s), GxP documents, Change Control documents

• Reviewing various system records for assignment, compliance, and closure

• Providing administrative support of electronic systems

• Reviewing procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy with local and international regulatory requirements

• Monitoring and reporting on trending metrics associated with site quality systems

• Actively participating in continuous improvement ideas, initiating, and implementing

• Participating in internal, regulatory and customer audits

• Training personnel on quality system processes

• May be supervising team members

This role might be for you if: 

• You demonstrate the ability to develop relationships and mentor business users on QMS system requirements

• You have excellent written, oral and interpersonal communication skills with ability to optimally interact with a broad spectrum of audiences

• You possess excellent time management, communication, and organizational skills along with a proven track record to multi-task required

• You have knowledge of quality and cGMP principles and systems and relevant regulatory guidelines

• You exhibit a drive for results, dealing with ambiguity, learning on the job and individual courage with a strong attention to detail

• You demonstrate project management skills with the ability to manage many diverse tasks simultaneously

• You effectively coordinate and manage work responsibilities under general guidance

• You are proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)

To be considered for this opportunity you must have a BS/BA in scientific discipline. For Principal Quality Systems Specialist: Requires a minimum of 8 years experience within Pharma or Biotech. Equivalent combination of education and experience will be considered. Senior Quality Systems Specialist: requires a minimum of 5 years experience within Pharma or Biotech. Equivalent combination of education and experience will be considered.

#JOBSIEPR #IRELIM #REGNIEQA #LI-Onsite

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.