Process and Procedures Quality Manager

Basking Ridge, NJ, United States
Sep 15, 2020
Required Education
Bachelors Degree
Position Type
Full time
We are looking for a Global Development, Process & Procedures (P&P) Quality Manager. Responsibilities include the quality and consistency of streamlined, procedural documents, Standard Operating Procedures (SOP), Work Instructions (WI), Guideline Documents (GD), Job Aids, BPTs, Forms and Templates.

In this role a typical day may include the following:
• Coordinating with P&P Operations to perform procedural document quality checks to ensure adherence to standards and overall consistency and compliance
• Identifying and evaluating issues and/or gaps in procedural document content during quality checks and collaborating with P&P Operations, and Author if applicable, to propose effective solutions
• Partnering with P&P Quality Lead to identify trends in metrics and provide recommendations for continuous improvements to further strengthen procedural document development
• Maintaining and enforcing high-level quality content standards, style guides, templates and P&P specific documents
• Performing impact assessments to identify potential misalignment with other procedures or overall GCP requirements
• Collaborating closely with Global Development Training, Global Development Systems and Process Improvement work streams to support quality consistency in high profile projects
• Encouraging a culture of continuous improvements by finding opportunities to further improve standards in accordance to GCP requirements.
• Maintaining a master list of procedural document Authors, SMEs, Reviewers and Approvers
• Interacting with GCP Quality groups, as needed, to fulfill SOP and related ad-hoc requests to support inspections

This role might be for you if you have:
• A minimum of 5 years' experience in a global regulated organization
• A minimum of 3 years' experience in a Quality role and experience in controlled procedural document principles, process design and styles, and leading process improvements
• Strong knowledge of GCP and regulatory requirements
• Excellent leadership with proven track record of interacting with all levels of the organization
• Excellent skills in project management, teamwork and managing complex situations
• Self-motivated with the ability to work effectively in a dynamic environment

To be considered for this opportunity you must have a BS/BA Degree with 5+ years relevant experience or MS degree and 4+ years relevant experience or 10+ years relevant experience in lieu of a college degree. Excellent problem solving, written and verbal communication skills. Ability to effectively handle multiple priorities and provide close attention to detail and accuracy of work

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.