Principal Quality Systems Specialist

Location
Tarrytown, NY
Posted
Oct 17, 2019
Ref
17991BR
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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

Summary: The Principal Quality Systems Specialist is a visible quality leader who develops/improves systems, executes quality event processing and approval, and coaches/facilitates users in implementing elements of the Global Quality Management Systems (QMS). This includes Deviation Management System (DMS), Change Management System (CMS) and inspection readiness, and metrics/process performance. The main objectives of this role are to review and approval quality events, serves as the Tarrytown point of contact for Quality System escalations, monitor Quality Systems processes performance, elevate indicators of trends and emerging trends, provide training on quality systems, and champion inspection readiness efforts for the global Quality Operations organization., This position will focus on Deviation, CAPA and Change Control Management elements of the QMS.

*Level to be determined based on qualifications relevant to the role*

Essential Duties and Responsibilities include, but are not limited to, the following:

• Overseeing the monitoring of QMS performance over time using statistical methods.

• Ensuring systems are fully implemented and integrated with other quality management systems.

• Leading/facilitating system based, and trend investigations identified during monitoring.

• Identifies recurring events and ensures appropriate actions are taken, such as Management notification and trend investigation.

• Facilitating the quarterly Tarrytown site metrics meeting and monthly Quality Operations meetings Ensure global alignment of processes, procedures and methods. Training system users.

• Provides on-site support to US and IRE sites for improvements and investigational activities

• Provides instruction led training on investigation methodologies and tools, change control and root cause analysis

• Keeps QA team members informed of the status of change initiatives and manages implementation of changes throughout the IOPS organization.

• Leading/facilitating continuous improvement initiatives based on user feedback, process monitoring results, etc. Partner with global counterparts to ensure effective and consistent implementation of continuous improvement initiatives or projects.

• Perform QA Review and Approval for Change Controls, CAPAs, and Deviations within electronic Quality System.

• Lead and document investigations for deviations ensuring identification of root cause and associated corrective/preventive actions

• Assist in/lead continuous improvement projects/initiatives

• Provides support and interface with customers regarding quality-related issues and procedures.

• Authoring and/or reviewing and approving investigation reports and change controls.

• Reviewing and approving SOPs

• Assists as needed in audits and inspections.

• May serve as IOPS liaison for Tarrytown based inspections and audits

• Champions the inspection readiness culture with Quality Operations and supports and improves the program behind it

• Discusses key issues and escalations for the Quality Systems processes based on voice of customer and voice of business and makes informed decisions

• Assist as needed with the review of Regulatory Intelligence (D-RISC) documents for impact to the Quality Operations functional areas.

• Other activities associated with projects, improvements, etc. as assigned.

• US site travel 10-20%, International site travel 5-10%

Knowledge, Skills and Abilities:

• Experience of the overall product development process preferred.

• Skilled in motivating, communicating with and instructing/training others, using both technical and non-technical language to explain complex subjects and processes.

• Comfortable making decisions independently but demonstrates good judgment in escalating issues to management and QA colleagues.

• Possesses the ability to change the thinking of or gain acceptance of others in sensitive situations.

• 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.

• Skilled in analyzing information of considerable difficulty and drawing valid conclusions; researching and gathering information related to customers, processes, systems; and managing multiple projects.

• Comprehension of quality and cGMP/GxP principles, Quality Management Systems, and relevant Global regulatory guidelines.

• Experience in performing investigations and investigation tools and methodologies

• General knowledge of document control and information and records management a plus

• Experience in application of statistics to quality systems.

• Excellent written, oral, and interpersonal communication skills.

• Excellent time and project management skills with the ability to manage several tasks simultaneously.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

• Working knowledge of Microsoft Project and/or SharePoint is a plus.

• Proficiency in electronic Quality Management Systems

Education and Experience:

• Sr Level - BS degree required in quality/engineering/science discipline and 5+ years of progressive/relevant professional experience required. MS with 7+ years.

• Principal Level -BS degree required in quality/engineering/science discipline and 8+ years of progressive/relevant professional experience required. MS with 7+ years.

• Knowledge of and experience with Quality Management Systems and Continuous Improvement methodologies (e.g. Lean, Six-sigma) and facilitation.

• Additional certifications desirable (e.g. Certified Manager of Quality, Engineering, Green Belt, and/or Auditor).

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, disability status, protected veteran status, or any other characteristic protected by law.
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