Associate Manager Document Control

3 weeks ago

Dublin, Dublin City, Ireland Regeneron Pharmaceuticals, Inc Full time

Summary: Manages and oversees Document Control and Archives operations. This includes oversight of the following: document workflows, records issuance, paper and electronic records archives, inspection support, projects, and metrics.

Essential Duties and Responsibilities include, but are not limited to, the following:

  • Manages direct reports (e.g. coordinators, Archivist, etc.) that may also have direct reports.
  • Establishes and communicates group and individual goals for group in accordance with department goals.
  • Partners with counterparts from sister sites to ensure global alignment of processes, systems and procedures, unified communication to user areas, and identification of system enhancements
  • Ensure timely prioritization of work and projects and adequate resource availability
  • Reports status of process performance and provides monthly metrics for presentation; includes Quality Operations systems metrics
  • Acts as the voice of Doc Control and the Archives for the Raheen site in manager's meetings and other cross-functional communications
  • Provides coaching and guidance to employees for performance and development
  • Assists in administration of the controlled document management system and records tracking system to ensure optimization as needed.
  • Site lead for Doc Control global teams, projects, and initiatives; continuously partnering with counterpart site leads
  • Interfaces directly with regulatory or partner inspectors, as needed, to represent documentation system and document archival
  • Provides advice to user departments on format, style, and architecture of documents to enhance standardization and clarity, and to minimize unnecessary changes.
  • Trains departmental staff in procedures and cGXPs, as well as training user departments in the documentation systems as needed.
  • Monitors expenses based on departmental budget.
  • Supports manager with data and analysis of resources and activities to allow for accurate headcount and workload forecasting for the Doc Control and Archives areas
  • Leads organizational design and Doc Control/Vault infrastructure requirements ensuring the optimal design of the team and operations
  • Supports global communication and visibility with manager through practices such as huddles and the Tier Board
  • Triggers and substances 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

Education and Experience:

  • Associate Manager: BA/BS in Science, Engineering, Technology & 8 + years of experience
  • Relevant experience in a cGMP environment.
  • Previous people management and/or team leadership experience required.

#LI-Onsite #IREADV #JOBSIEPR #REGNIEQA

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location. #J-18808-Ljbffr

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