The Global Development Process & Procedures (P&P) Operations Manager is responsible for the day-to-day operations supporting the development and management of streamlined, processes and procedural documents (Standard Operating Procedures (SOP), Work Instruction (WI), Guideline Document (GD), Job Aids, Forms and Templates) portfolio.
In this role, a typical day might include:
Lead, moderate the revision/creation procedural documents through the document lifecycle including medium to low priority, revisions for process improvements, retirements and administrative changes
Facilitate process mapping and updating process content and retirement workflows in collaboration with Author/SMEs, using tools such as process maps, value stream mapping – to ensure fit for purpose process are defined
Assess gap and impact assessments to identify overall scope of projects assigned
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
Support the development of controlled procedural document projects by collaborating with functional owners and cross-functional SME(s) to support improvement of existing processes
Maintain Global Development procedural document portfolio for assigned functional areas
Assist other P&P team members with complex procedural document projects, CAPAs and high priority assignments, as needed
Collaborates with Global Development Training and Technical Training, when applicable, to ensure training requirements are implemented for assigned roles in procedures
This role may be for you if you:
Demonstrates proven track record in the design/development of SOPs, supporting documents and forms/templates
Strong knowledge of GCP and regulatory requirements
Strong organizational and project management skills
Demonstrates influencing and negotiating skills with the ability to communicate effectively at all levels of the organization
Demonstrates skills in problem solving, working independently and in a team environment
Experience using Electronic Document Management systems
Experience in Microsoft Visio or other process mapping ability
Ability to multi-task and handle conflicting/changing priorities
To be considered, you must have a Minimum 5 years’ experience in a global regulated organization and minimum 3 years’ experience in a Process role with experience in controlled procedural document principles, process design and styles.
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.