Regeneron Pharmaceuticals
Manager Process & Procedures Operations
This job is now closed
Job Description
- Req#: R32356
- Lead, moderate the revision/creation procedural documents through the document lifecycle including medium to low priority, revisions for process improvements, retirements and administrative changes
- Support development of processes applying tools such as process maps, value stream mapping – to ensure fit for purpose process are defined
- Support the development of controlled procedural document projects by collaborating with functional owners and cross-functional SME(s) to support improvement of existing processes
- Facilitate process mapping and updating process content and retirement workflows in collaboration with Author/SMEs
- Coordinate the review cycles of assigned procedural documents and approval workflows
- Identify and evaluates issues and/or gaps in processes and propose effective resolutions
- Partner with P&P Quality Lead and P&P Quality Managers to strengthen quality procedural documents and evaluate quality check findings
- Maintain Global Development procedural document portfolio for assigned functional areas
- You have demonstrated proven track record in the design/development of SOPs, supporting documents and forms/templates
- You have proven understanding of GCP and regulatory requirements
- You have strong interpersonal and project management skills
- You can demonstrate influencing and negotiating skills with the ability to optimally effectively at all levels of the organization
- Experience using Electronic Document Management systems, Microsoft Visio or other process mapping ability is helpful
The Global Development Process & Procedures (P&P) Operations Manager is responsible for the day-to-day operations of the development and management of streamlined, procedural documents (Standard Operating Procedures (SOP), Work Instruction (WI), Guideline Document (GD), Job Aids, Forms and Templates) portfolio.
A typical day may include the following:
This role might be for you if:
To be considered for this opportunity, you must have at minimum a Bachelor's Degree with 7+ years of experience in a global regulated organization, 3 of those years in a quality role with experience in controlled procedural document principles, process design and styles.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
About the company
Regeneron Pharmaceuticals, Inc. is an American biotechnology company headquartered in Westchester County, New York.
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