Regeneron Pharmaceuticals Process and Procedures Business Partner in Tarrytown, New York
The Process & Procedures (P&P) Business Partner is responsible for translating business and regulatory requirements for assigned business units into the delivery of controlled procedural documents. This role is also directly responsible for executing procedural documents that drive quality and compliance.
In this role, a typical day might include:
• In collaboration with senior stakeholders, identifying the need for new or updated procedural documentation
• Liaising with functional partners, GCP Quality, QAA and Development Systems to identify current process gaps for assigned functional areas against policies and regulations to ensure compliance and propose effective solutions
• Working with partners in assigned areas to review book of work (ongoing and forecasted) to ensure priorities are understood and aligned with P&P Governance
• Presenting stakeholder documentation requests to P&P Governance for triaging, prioritization and resource assignment, and ensuring scope and need to clear
• Serving as point of contact for process and procedure needs
• Establishing, strengthening and sustaining key relationships to understand and forecast business needs, priorities, and challenges
• Being accountable for the delivery of on time, high quality procedural documents and performance tools across by collaborating with procedural documentation writers, quality managers and coordinators
• Ensuring document scope is maintained; communicating any risks or issues as appropriate
• Collaborating with Global Development Training and PMO Business Partners to identify, craft and implement continuous improvement opportunities within the process development space
This role may be for you if:
You have experience working in or with GCP Quality, QAA and Development Systems
You have the ability influence across multiple invested groups who may have opposing priorities
You have the ability to think operationally and strategically
You're an influential leader with a proven track record to work with Senior Leaders and navigate through complex situations
To be considered for this opportunity you need a Bachelor's degree and a minimum of 10 years experience. Less experience might be considered for those with Advanced degrees. Experience in procedural document principles, process design, and leading process improvements is required. Solid understanding of GCP and regulatory requirements is also a must.
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.