Sr. Manager, Quality Assurance

Rensselaer, New York, US
Oct 09, 2018
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: Responsible for providing professional expertise and leadership in the Quality Risk Management function on a global scale. Individual will proactively identify and implement industry best practices for GMP Quality Risk Management, including but not limited to internal processes that support manufacturing, quality control, materials management, validation and quality assurance.

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

• Develop and maintain quality risk management system supporting the function of Industrial Operations and Product Supply (IOPS) division at a global scale.

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

• Establish training requirements for IOPS staff in quality risk management principles and practices.

• Oversee timely facilitation and completion of risk activities.

• Manage data analysis and statistical tools used to support quality risk management activities.

• Manage personnel in multiple IOPS sites.

• Communicate the outcome from quality risk management activities and periodic IOPs-wide reviews.

• Ensure appropriate application of quality risk management in IOPS overall Quality System.
Education and Experience:

• Requires BA/BS degree in life sciences, engineering or other relevant discipline with 8+ years of experience of pharmaceutical manufacturing, medical device/combination product manufacturing, or design and development risk. Equivalent combination of education and experience will be considered.

• Thorough understanding and experience with Quality Risk Management principles, tools, and systems.

• Demonstrated leadership skills.

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.