Senior Operations Manager, Process & Procedures, SOP Documentation

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:

The Global Development Process & Procedures (P&P) Operations Senior 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.

Job Duties:

• Manage controlled procedural document projects by collaborating with functional owner and cross-functional SME(s) to support the development and improvement of processes

• Lead new and significantly revised procedural documents through its lifecycle including high priority and visable projects, complex cross-functional processes, inspection commitments, audit corrective action/preventive action (CAPAs) and critical gaps

• Faciliate process mapping and creating/updating process content in collobration with Author/SMEs

• Partner in cross-functional process improvement initiatives resulting in new or revised procedural documents

• Assess impact assessments to identify overall scope of projects assigned

• Lead 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

• Participate and contribute to overall P&P improvements to ensure the highest quality and compliance of deliverables, in partnership with P&P Operations Lead, P&P Business Partners and P&P Quality Lead

• Collaborates with Global Development Training and Technical Training, when applicable, to ensure training requirements are implemented for assigned roles in procedures

• May oversee deliverables and/or mentor junior P&P Managers, as needed

Educational requirements:

• BS/BA Degree with 6+ year's relevant experience or MS degree and 4+ year's relevant experience

Experience:

• Minimum 7 years' experience in a global regulated organization

• Minimum 5 years' experience in a quality role with experience in controlled procedural document principles, process design and leading process improvements

• Demonstrates proven ability in the design/development of SOPs, supporting documents and forms/templates

• Strong knowledge of GCP and regulatory requirements

• Strong leadership, organizational and project management skills

• Demonstrates strong 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 is preferred

• Experience in Microsoft Visio or other process mapping ability is preferred

• Ability to multi-task and manage conflicting/changing priorities

Core Behavioral Competencies:

• Leadership

• Executive Presence

• Stakeholder Management

• Project Management

• Process Management

• Strategic Thinking

• Critical Thinking & Problem Solving

• Integrity and Trust

• Negotiating

• Organizational & Political Savvy

• Dealing with ambiguity & paradox

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

LMR, #LI-LR1