Assoc. Manager / Manager, Quality Assurance

Rensselaer, NY, United States
Jan 19, 2019
Quality, Quality Control
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: Supports the work of Regeneron's Industrial Operations and Product Supply (IOPS) site at Raheen through the use of quality risk management principles and techniques. The scope may also include collaboration with other IOPS Sites and partners and their respective programs.

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

• Manage and continually improve Quality Risk Management (QRM) system supporting groups identified in the summary.

• Formulate risk management strategies, principles, methods and tools, and document in appropriate Regeneron policies, procedures, and reports.

• Educate and train staff (cross sites) in quality risk management principles and practices and act as a subject matter expert and resource for QRM matters.

• Manage and lead data driven risk assessments (risk identification, analysis and ranking).

• Responsible to develop and manage data analysis and statistical tools used to support quality risk management activities.

• Oversee QRM program to ensure risk assessments are conducted as required frequencies and manage the overall process, tasks, and communications

• Communicate the outcome from quality risk management activities to all business partners

• Work with the management team to integrate quality risk management concepts and philosophies into the overall Quality System.

• Function as a fully integrated member of the Quality Assurance management team, advising on all QRM matters within the IOPS organization, as well as being the primary interface with customers

• Represent Regeneron's approach to Quality Risk Management during regulatory inspections and partner audits.
Education and Experience:

• Requires BS/BA in Life Sciences with 6+ years of relevant progressive experience in QA within the Pharma / Biopharma industry.

*Level will be determined based on skills and experience relevant to the role.*

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.