National Labor Exchange Veterans Jobs

USNLX Veterans Careers

Job Information

Regeneron Pharmaceuticals Manager, Document Control in Rensselaer, New York

The Document Control Team is hiring an Manager! As the Associate Manager, Document Control, you will lead and supervise Document Control operations including: document workflows, records issuance, paper and electronic records archives, technology, inspection support, projects, logistics and metrics.

Shift Available:

  • Monday - Friday, 10am-6:30pm, EST

In this role, a typical day may include:

  • 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 TAR, REN and or RAH counterparts to ensure global alignment of processes, systems and procedures, unified communication to user areas, and identification of system improvements

  • Acts as the voice of Document Control the site in manager’s meetings and other cross-functional communications

  • Provides coaching and guidance to employees for performance and development

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

  • 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 global communication and transparency with manager through practices such as huddles and the Tier Board

  • Triggers and sustains communication with areas to gather feedback to improve processes helping the business to understand DC and/or IRM processes and improve overall efficiency and effectives of our systems

  • Oversees document logistics room during regulatory and partner inspections, including determining and maintaining cross functional staffing and other support resources.

  • Leads teams responsible for workflow planning and scheduling

  • Maintains relationships with external departments such as manufacturing to schedule workflow and records issuance activities and functions as a leader between these areas to facilitate schedule adherence

  • Oversees scheduling activities based on business change schedules and adherence to the change schedules (TADs, Dynamic windows, standard lead time

  • Develops metrics to monitor the performance of the area, systems and processes, identifies key performance indicators, and analyzes data to identify improvements

  • Oversee process of translating the bundle of change controls to demand on Doc Control resources/creating subsequent workflow schedule

This role might be a fit for you if you have:

  • Experience in a cGMP environment.

  • Knowledge of Documentation Management Methodologies.

  • Strong internpersonal skills.

  • Strong technical writing skills.

  • Working knowledge of electronic documentation and quality management systems.

To be considered for this role, you must hold a Bachelor's degree and the following minimum years of experience for each level:

  • Associate Manager: 6+ years

  • Manager: 7+ years

  • Sr. Manager: 8+ years

May substitute proven equivalent combination of education and experience. Level is determined based on qualifications relevant to the role.

#REGNQA

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.

Salary Range (annually)

$89,100.00 - $199,000.00

DirectEmployers