Associate Director, Document Control
- Regeneron Pharmaceuticals, Inc.
- Rensselaer, New York
- Start date
- Mar 2, 2023
- Regulatory, Research/Documentation
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Pharm Country, Best Places to Work
We are currently looking to fill an Associate Director, Document Control position. This position leads and supervises US Document Control (DC) operations and processes and advises the activities of the DC management team. This includes oversight of the following areas: document workflows, records issuance, technology, inspection readiness, continual improvement, inspection support, projects, planning, logistics and metrics. Ensures partnerships are built and maintained with areas DC supports to drive high quality throughput via efficient and effective methods.
In this role, a typical day might include the following:
Establishes departmental goals aligned with the business and organizational goals
Ensures timely prioritization of work and projects and adequate resource availability
Provides coaching and guidance to employees for performance and development
Supports organizational design ensuring optimal design of the team and operations
Supports global communication and visibility with managers through practices such as huddles and management team meetings
Directs and continuously improves Doc Control processes ensuring that performance and quality conform to regulatory standards and internal requirements
Provides leadership and collaboration within and across the organization
Partners with global counterparts to ensure global alignment of processes, systems and procedures, unified communication to user areas, and identification of system enhancements
Initiates and sustains communication with business areas to help the business understand DC processes and to improve the overall efficiency and effectives of our systems
Identifies risks to operations and works with team and business to identify and implement mitigations
Provides on the floor guidance for inspection readiness and cultivates the culture of safety, cleanliness and compliance
Develops personnel, supports a positive, diverse, equal and inclusive work environment and builds a strong team.
Planning & logistics
Ensures appropriate resourcing for document schedule planning adherence
Develops resourcing strategies to plan the operating budget and headcount budget and forecast to ensure maximum utilization of personnel to fulfill department objectives
Maintains relationships with external departments to understand feeders that will affect resource usage and needs and proactively identify and mitigate issues
Technology & systems
Accountable for creating pathways for communication of key information to business areas, ensuring accurate data is visible and usable
May serve as Business Process Owner of area owned systems
Health & metrics
Reports status of process performance and ensures on-time and accurate metrics for presentation; includes weekly operations, Quality Operations systems metrics and Right To Operate
Site lead for DC global teams, projects, and initiatives
Supports business driven Global/cross-site improvement projects
Works with department management to create a robust inspection readiness program, champion an inspection ready mentality and ensure documentation generation and maintenance all supporting successful inspections
May be involved in Regulatory Agency interactions and preparation as related to site inspections and ensures regulatory observations are adequately addressed and completed on schedule
This role may be for you if you:
Have solid understanding and technical experience in a Document Control/Information and Records Management operations and methodologies, and experience in start-up environment
Are knowledgeable in applicable federal, state and local regulations, rules, policies and procedures
Can make decisions independently with demonstration of good judgment in calling out issues to management and QA colleagues
Can influence and lead with and without direct line authority
Are skilled in analyzing information of considerable difficulty and drawing valid conclusions
Have proven leadership skills and strong interpersonal skills
Excel in high-energy, fast paced environment with changing priorities
To be considered for this role you must hold a Bachelor’s degree in and 10+ years of relevant experience in a cGMP environment. Previous people management and/or team leadership experience required.
May substitute proven experience for education requirement.
#REGNQADoes 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)$139,200.00 - $227,200.00
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
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