Summary: Responsible for the management and oversight of the QA Operations, Document Control (DC) function. This role will be part of the QA Operations site management team. This role includes oversight of the following areas: Document workflows, Records Issuance, Information & Records Management, Technology, Inspection Readiness & Support, Continual Improvement, Projects, Planning, Logistics and Metrics. Ensures partnerships are built and maintained with areas DC supports to drive high quality throughput via efficient and effective processes.
Essential Duties and Responsibilities include, but are not limited to, the following:
Ensures timely prioritization of work and projects and adequate resource availability.
Provides coaching and guidance to employees for performance and development.
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.
Drives initiatives supporting departmental growth and organizational objectives to improve processes, reduce waste and improve efficiency.
Provides leadership and collaboration within and across the organization at all levels, across functional groups.
Partners with US 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.
Partners and collaborates with the respective customer and department management within their sphere of influence to develop and support department and customer initiatives.
Identifies risks to operations and collaboratively works with team and business to identify and implement mitigations.
Provides on the floor guidance to the team and business areas for inspection readiness and fosters the Regeneron Way and IOPS culture of safety, cleanliness, and compliance.
Develops personnel, supports a positive, diverse, equal, and inclusive work environment and builds a high-performing team.
PLANNING & LOGISTICS
Ensures appropriate resourcing for document schedule planning adherence.
Develops resourcing strategies to plan and manage the operating budget and headcount budget and forecast to ensure maximum utilization of personnel to fulfill department objectives.
Manages relationships with external departments to understand feeders that will impact resource usage and needs and proactively identify and mitigate issues.
Defines and implements quality standards, systems, and metrics for DC to ensure performance, compliance, effectiveness, efficiency, and value to the business in line with department goals.
Oversees area relevant improvement projects driven by the business priorities (global and local).
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. BUSINESS PRIORITIES
Site support for DC global teams, projects, and initiatives; continuously partnering with counterpart site leads.
Supports business driven Global/cross-site improvement projects.
Works with department management to maintain a robust inspection readiness program, foster an inspection ready mindset and ensure documentation generation and maintenance all supporting successful inspections.
Involved in Regulatory Agency interactions and preparation as related to site inspections and ensures regulatory observations in their area are adequately addressed and completed on schedule.
Education and Experience:
Requires BA/BS degree and at least 8 years of experience or equivalent combination of education and experience in a pharmaceutical/biologics manufacturing environment.
Previous people management and/or team leadership experience required.
Knowledge, Skills, and Abilities:
Ideal candidate would have working knowledge and technical experience in a Document Control/Information and Records Management operations and/ or experience in Quality Systems operations.
Comfortable making decisions independently with demonstration of good judgment in escalating issues to management and QA colleagues.
Ability to negotiate, influence and lead with and without direct line authority.
Skilled in analyzing information of considerable difficulty and drawing valid conclusions.
Demonstrated leadership skills and strong interpersonal skills.
Excels in high-energy, fast paced environment with changing priorities.
#IRELIM #JOBSIEPR #REGNIEQA #LI-Onsite
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.