Quality Lead, Global Development Process and Procedures

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) Quality Lead is directly responsible for driving quality management disciplines of the development and maintenance of streamlined, procedural documents (Standard Operating Procedures (SOP), Work Instruction (WI), Guideline Document (GD), Job Aids, Forms and Templates) portfolio.

Job Duties:

• Accountable for the delivery of quality procedural documents to P&P Operations

• Oversee and manage the day-to-day operations of P&P Quality Managers to ensure high quality documentation, adherence to standards, and overall compliance of deliverables

• Partner with P&P Business Partners and P&P Operations to establish and drive consistency in standards (content and style) and procedural document templates and across all P&P output

• Define and maintain procedural document templates (SOP, WI, GD, etc.) and style guides

• Manage issues and/or gaps in procedural document content during quality checks and collaborate with procedural document P&P Operations, and Author as needed, to propose effective resolutions

• Foster a culture of continuous improvements by identifying solutions to further enhance standards in accordance with GCP requirements

• Lead the production of quality metric reporting to identify trends in document quality and provide recommendations for continuous improvements to further strengthen procedural document development methods

• Collaborate with Global Development Training, Global Development Systems and Process Improvement work streams to support high profile projects

• Manage a master list of procedural document Authors, Subject Matter Expert(s), Reviewers and Approvers

• Collaborate with GCP Quality Inspection Readiness Representatives to fulfill SOP and ad-hoc related requests to support inspections

• Negotiates complex situations without direct authority

• In collaboration with P&P Operations and Business Partners liaise with GCP Quality Management to identify & manage process deviations

• Liaise with P&P Business Partners, P&P Operations Lead and GCP Quality Management Clinical Compliance Representatives for all internal Quality Auditing & Assurance Corrective Actions/Preventive Actions (CAPAs) that result in procedural document changes
Supervisory Responsibilities:

• Manage at least two direct reports.

Requirements:

• A minimum of 10 years' experience in a global regulated organization

• A minimum of 8 years' experience in a quality role with experience in controlled procedural document principles, process design and styles, and leading process improvements

• A minimum of 5 years' experience in Line Management including experience in mentoring and coaching direct reports

• Strong knowledge of GCP and regulatory requirements

• Strong leadership with demonstrated ability to interact with all levels of the organization

• Demonstrated success in managing teams and projects by maintaining a high level of productivity and quality work products

• Demonstrated success in project management, stakeholder management, collaboration and negotiation of complex situations

• Self-motivated with the ability to work effectively in a dynamic environment

• Excellent problem solving, written and verbal communication skills

• Advanced technical skills: Word, Excel, Visio, electronic document management system

• Ability to effectively manage multiple priorities with a sense of urgency

• Provides close attention to detail and accuracy of work
Core Behavioral Competencies:

• Leadership

• Executive Presence

• Stakeholder Management

• Project Management

• Process Management

• Line Management

• Strategic Thinking

• Critical Thinking & Problem Solving

• Integrity and Trust

• Negotiating

• Organizational & Political Savvy

• Dealing with ambiguity & paradox

BS/BA Degree with 10+ years relevant experience. MS degree and 8+ years relevant experience.

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, Process and Procedures, Training, Organizational Dev, Performance Learning, Quality, KPI