Associate Director- Process & Procedures Operations Lead, GCO

Location
Tarrytown, NY
Posted
Oct 16, 2019
Ref
17472BR
Required Education
Bachelors Degree
Position Type
Full time
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 Lead is directly responsible for driving the 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.

Responsibilities:

• Accountable for the delivery of quality procedural documents to functional areas/stakeholders

• Oversee and manage the day-to-day operations of P&P Operation Managers to ensure adherence to standards and compliance for creating, updating and retiring procedural documents

• Contribute to continuous improvements in standards (content and style) and procedural document templates in partnership with P&P Quality Lead

• Analyze impact assessments for new and revised procedural document requests

• Liaise with P&P Quality to ensure procedural document quality checks are performed in the agreed timeframe

• Collaborate with P&P Quality Lead to identify trends in metric reports and provide recommendations for continuous improvements to further strengthen procedural document development methods

• Maintain the master Global Development procedural document portfolio

• Collaborate with P&P Business Partners for prioritization and forecasting workload

• Manage and maintain electronic document management system (EDMS) including workflows, folder structure, etc. and interact with system owners as needed

• Liaise with P&P Quality and oversee the preparation of documents for inspection requests (SOP lists, etc.)

• Liaise with P&P Quality Lead to support internal Quality Auditing & Assurance Corrective Actions/Preventive Actions (CAPAs) that result in procedural document changes

• Liaise with GCP Quality Improvement Representatives to identify trends for open process deviations

Supervisory Responsibilities:

• Manages several direct reports

Requirements:

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

• 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

• In-depth 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

• Negotiates complex situations without direct authority

• 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

Location: Tarrytown or Basking Ridge

#LI-SC1, SKC

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.