Manager, PV Compliance, Quality & Compliance

Location
Tarrytown, New York, US
Posted
Oct 24, 2018
Ref
13892BR
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:

This is an individual contributor role, reporting to head of Quality and Compliance, PV.

This position is responsible for the ongoing monitoring of quality metrics associated with PV deliverable, including but not limited to safety submissions performed by Regeneron and its vendors. This position will work collaboratively across functions to identify root cause, corrective action, and preventative action, and participate in corporate-wide compliance discussion (e.g., SSN) as needed.

Duties:

Adhere to the established processes and timeline for monitoring and compiling compliance metrics

• Work effectively with other PV sub-functions and relevant personnel to effectively discuss compliance issues to identify and document root cause, corrective action, and preventative action. Escalate broader concerns to PV management and other functions as needed to ensure compliance with regulatory requirements.

• Participate in cross-functional discussion on compliance that relate to PV deliverables.

• Participate in the continuous process improvement effort within the function to identify gaps and advise management accordingly.

Requirements:

-Good communication skills, both written and verbal.
- Ability to multi-task and effectively manage demanding timeline
- Ability to work collaboratively across functions and roles
- High level of accountability; drive results
- Experience in compliance management preferred.
10 years of industry experience
- Bachelors Degree Required

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.