Associate Manager Document Control

Within this role you will be responsible for managing and overseeing document control and archives operations. This includes oversight of document workflows, records issuance, paper and electronic records archives, inspection support, projects, and metrics.

As an Associate Manager Document Control, a typical day might include, but is not limited to, the following: 

• Managing direct reports (e.g. coordinators, archivist, etc.) that may also have direct reports

• Establishing and communicating group and individual goals in accordance with department goals

• Partnering with counterparts from sister sites to ensure global alignment of processes, systems and procedures, unified communication to user areas, and identification of system enhancements

• Ensuring timely prioritization of work and projects and adequate resource availability

• Reporting status of process performance and providing monthly metrics for presentation; including quality operations systems metrics

• Acting as the voice of doc control and the archives for the Raheen site in manager’s meetings and other cross-functional communications

• Providing coaching and guidance to employees for performance and development

• Assisting in administration of the controlled document management system and recording tracking system to ensure optimization as needed

• Site leading for Doc Control global teams, projects, and initiatives; continuously partnering with counterpart site leads

• Interfacing directly with regulatory or partner inspectors, as needed, to represent documentation system and document archival

• Providing advice to user departments on format, style, and architecture of documents to enhance standardization and clarity, and to minimize unnecessary changes

• Training departmental staff in procedures and cGXPs, as well as training user departments in the documentation systems as needed

• Monitoring expenses based on departmental budget

• Supporting manager with data and analysis of resources and activities to allow for accurate headcount and workload forecasting for the doc control and archives areas

• Leading organizational design and doc control/vault infrastructure requirements ensuring the optimal design of the team and operations

• Supporting global communication and visibility with manager through practices such as huddles and the tier board

• Triggering communication with areas to gather feedback to use to improve processes allowing the business to understand our processes and improve overall efficiency and effectives of our systems

This role might be for you if:

• You have strong knowledge and understanding of equipment used for QC analysis and operations

• You have a strong background and are familiar with site change control, risk management and data integrity initiatives/programs

• You have the ability to communicate with transparency

• You are a dedicated leader who can train, mentor and lead employees

To be considered for this opportunity you should have BA/BS in Science, Engineering, Technology & 8 + years of experience. You should have relevant experience in a cGMP environment. Previous people management and/or team leadership experience required.

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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.