QA Project Specialist (Quality Operations)
Regeneron Pharmaceuticals, Inc.
Tarrytown, New York, United States
Job type: fulltime
Job industry: Other
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.
The QA Project Specialist will support the Quality Operations functional area focusing on Quality Planning and Quality Performance by leading QA projects and/or overseeing the QA project portfolio, as well as monitoring and improving Quality Operations process compliance and performance.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Leads the QA Strategic Planning program identifying and prioritizing projects, helping project leads construct project A3s and associated project tool kit, and overseeing project status review meetings.
• Oversees multiple related projects to ensure interdependencies are visible, managed and aligned. Proactively identifies when delays may occur due to interconnections and develops solutions to avoid these delays.
• Monitors the Project Tracker ensuring QA Staff awareness of due dates, escalation of issues, and issuance of metrics
• Responsible for interdepartmental and assigned cross-functional project management activities ensuring project timelines, costs, and goals are met.
• Inform Quality management of issues and progress of assigned projects.
• Lead or facilitate teams to accomplish the deliverables, milestones, and objectives meeting the plans and schedules ensuring that any changes to the plans are communicated and agreed to by the teams and project sponsors
• Leads or facilitates continuous quality improvement projects and quality review processes.
• Provides support and interface with customers regarding quality-related issues and procedures.
• Maintains and monitors the Continuous Improvement Tracker ensuring QA Staff awareness of idea disposition and QA management project assignment. Ensure that all actions are assigned appropriately and monitor the improvements that become QA projects.
• Supports QA record/document initiation, review, and approval
• Monitors and reviews area performance and compliance status against processes and procedures to help maintain a state of inspection readiness across IOPS and other business areas
• Supports on-site and off-site inspections, audits, and mock-inspections
• Leads area walk-throughs
• Assist in/lead continuous improvement projects/initiatives
• May require 5-10% travel based on business needs.
Knowledge, Skills & Abilities:
• Knowledge of project management techniques and practices, PMP certified desirable
• Skilled in motivating, communicating with and instructing/training others, using both technical and non-technical language to explain complex subjects and processes.
• Ability to negotiate, influence and lead with and without direct line authority, and to engage others and lead an organization through continuous improvement and change is required.
• Ability to manage multiple tasks and ensure on-time completion
• Comfortable making decisions independently but demonstrates good judgment in escalating issues to management and QA colleagues.
• Strong interpersonal skills
• Working knowledge of MS Word, XL, PPT, Access, learning management system, electronic document management systems, electronic quality management system
Education & Experience:
• Associate Specialist - BS degree required in quality/engineering/science/management discipline and 0-2+ years of related work experience required
• Specialist - BS degree required in quality/engineering/science/management discipline and 2+ years of related work experience required
• Sr Specialist - BS degree required in quality/engineering/science/management discipline and 5+ years of related work experience required
• Prior project management experience required
• Additional certifications appropriate to the job will be considered first (e.g. Certified Manager of Quality, Engineering, Black Belt, Auditor).
*Level will be determined based on skills and related 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.