Manager, Process & Procedures Operations

Posted 6 Days Ago
Be an Early Applicant
Basking Ridge, NJ
113K-185K Annually
Senior level
Biotech • Pharmaceutical
The Role
The Manager of Process and Procedures Operations ensures quality review of procedural documentation and system metadata. Responsibilities include managing workflows for quality improvements, preparing impact assessments, supporting inspection management, and negotiating complex situations. The role requires critical thinking and the ability to manage multiple priorities effectively.
Summary Generated by Built In

The Manager Process and Procedures Operations is responsible for the quality review of procedural documentation and system metadata to ensure deliverables adhere to standards and identify and evaluate issues and/or gaps in procedural document content; in collaboration with P&P Ops Mgr and Author, propose effective solutions.

In this role, a typical day might include:

  • Manage workflows for Administrative and simple quality changes
  • for continuous improvements to further strengthen procedural document development
  • Prepares project-specific initial impact assessment
  • Support inspection management activities by providing copies of procedural documents, as requested
  • Negotiates complex situations without direct authority

This role might be for you if have:

  • Solid understanding of GCP, GVP and regulatory requirements
  • Demonstrated proficiency in project management, collaboration and negotiation of complex situations
  • Self-motivated with the ability to work effectively in a dynamic environment
  • Ability to apply critical thinking and situational analysis to solve problems and manage multiple priorities with varying levels of urgency

To be considered for this opportunity, we require a Master's degree and 4 years of relevant experience or a Bachelors degree with 7 years of experience. We also require you to be onsite in one of our offices three days a week

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)

$113,100.00 - $184,700.00

Top Skills

GCP
Gvp
The Company
HQ: New York, New York
15,000 Employees
Hybrid Workplace
Year Founded: 1988

What We Do

At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.

Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media.

An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.

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