Head, Process Excellence
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Basking Ridge, New Jersey
- Start date
- Sep 23, 2021
View more
- Discipline
- Engineering, Manufacturing & Production, Process
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
The Head, Process Excellence is accountable for driving Global Development process excellence through the creation and maintenance of Global Development’s procedural document portfolio required for compliance with regulations and the application of consistent Business Practice.
The Head will lead a team of 4-6 process excellence professionals (Process Writers, Quality Managers and Business Partners) who collaborate with Process Owners and SMEs across Global Development to author documentation in response to business needs and changing regulations, and manage review and approval workflows and the overall documentation library
In this role, a typical day might include:- Leading the expansion of the Process Owner model for GD, defining and driving the Process Owner strategy and execution of that strategy (Control Plan through KPI monitoring, process improvement activities, process design, process change support)
- Chairing Process Owners Network to ensure process health and alignment across Global Development
- Chairing Process Governance to ensure the health of our process documentation over time
- Closely liaising with Global Development Quality, Functional Area Leadership and Process Owners;
- Ensuring all projects are resourced appropriately based on prioritization and risk
- Securing resources from management as vital within P&P and the business functions.
- Ensuring Quarterly P&P business reviews with key partners occur tracking delivered results, status of key projects, and proposed strategic changes
- Owning Content Standards, Templates and end-to-end document development process to ensure consistent implementation and alignment with ideal practices and optimization over time.
- Being accountable for the production and oversight of quality metrics; monitoring deliverables, performance, and results to influence potential opportunities for improvement
- Owning implementation of a new Electronic Document Management System for Global Development and serving as the system owner on an ongoing basis
- Being responsible for developing a system Governance model to oversee document change control
- Partnering with GD Quality Management and Clinical Compliance Heads for all Corrective Actions/Preventive Actions (CAPAs) that result in procedural document changes ensuring the Delivery team delivers according to agreed strategy
- Ensuring all Inspections and Audits are supporting appropriately
- Partnering with Change Management to systematically outline current to future state documentation changes to drive Change Management, Communication and Training Strategies
- Support the PMO and Continuous Improvement teams in Global Development initiatives to ensure P&P support meets or exceeds partner expectations
- Being accountable for P&P Business Partner Stakeholder Management Strategy and Engagement Model
- Overseeing and directly managing P&P Operations & Quality Lead, and P&P Business Partners
- Ability to travel up to 25%
You are a strong leader with demonstrated ability to influence across all levels of the organization
You have demonstrated success in managing teams and projects by maintaining a high level of productivity and quality work products
You are skilled in project management, partner management, collaboration and negotiation of complex situations
You are self-motivated with the ability to work effectively in a dynamic environment
You can effectively balance multiple priorities and act with resolve in a fast paced, ambiguous environment
To be considered, you must have a Bachelor's degree with at least 12 years of experience in a global regulated organization, as well as at least five years of line management. Eight years of proven experience in quality, continuous improvement or operational excellence is ideal, including experience with controlled procedural documents, process design and styles and leading process improvements. Advanced technical skills in Word, Excel, Visio, and EDMS are vital.
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 amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity 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.
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Company
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
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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