Associate Director, Quality & Compliance PV

Location
Tarrytown, New York, US
Posted
Jul 31, 2018
Ref
13884BR
Required Education
Other
Position Type
Full time
Position Summary

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 position is responsible for managing staff and activities related to ICSR case quality reviews, ongoing monitoring of departmental compliance, and trending of quality and compliance metric to identify process improvements and advise the head of PV.
This role will also provide support to department's effort in maintaining preparedness audits and health authority inspections. This is a supervisory role with individual contributor responsibilities.

Duties:

Maintain an accurate and timely system for monitoring / managing compliance with all case reporting requirements (eg, with health authorities, license partners, contract research organizations).

• Maintain an accurate and timely system for monitoring/ managing quality of all cases processed by PV, including its vendors

• Work effectively with other PV sub-functions and relevant personnel to effectively discuss quality and compliance issues and identify timely solutions.

• Provide support for quality review of additional PV deliverables, such as Safety Agreements, PAERs, Safety Management Plans

• Responsible for management of assigned Quality & Compliance staff; this includes but is not limited to management of job performance, career development and training.

• Maintain appropriately comprehensive SOPs and WIs for Quality & Compliance activities.

Requirements:

-Excellent communication skills, both written and verbal.
- Ability to multi-task and effectively manage demanding timelines
- Ability to work collaboratively across functions and roles
- High level of accountability; drive results
-Experience in a pharmaceutical industry with at least 2 years of people management experience
- 10 years of industry 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.