Assoc. Manager, Quality Compliance (Complaints)

Rensselaer, New York, US
May 18, 2018
Required Education
Bachelors Degree
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: Oversees a team focused primarily on providing support related to receiving and processing complaint notifications.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Oversee personnel and processes that provide support related to receiving and processing complaint notifications to include:
o Monitoring complaint notifications from group mailbox.
o Entering complaint intake data into Process Compliance system and Complaint Master tracking sheet.
o Corresponding with personnel and contractors (Call Center, Regeneron Distribution, Clinical Trial Management, etc.) as required to request or obtain additional information related to complaint reports.
• Organize resources to meet goals and timings, coordinate prioritization of activities with area management.
• Support development and implementation of system improvements.
• Review/approve complaint and event records in Process Compliance.
• Represent QA Product Compliance in cross-functional and multi-site teams in support of Quality harmonization and improvement initiatives.
• Provide support for regulatory and partner audits.
• Identify gaps in systems and develop feasible plans for correction.
• Facilitate continuous improvement initiatives specific to function.
• Ensure appropriate training programs are executed related to areas of responsibility.

Knowledge, Skills and Abilities:
• Demonstrated supervision and leadership skills.
• Experience with coaching and conflict resolution.
• Ability to be accountable for team's performance and results.
• Ability to interpret and communicate information with transparency.
• Ability to identify and effectively communicate risks.
• Ability to manage internal and external relationships.
• Ability to handle issues appropriately and with a sense of urgency.
• Ability to prioritize based on business needs.
• Ability to work independently or as part of a team.
• Ability to identify root cause and solve problems.
Education and Experience:
• Requires BS/BA in scientific discipline or related field preferred with 6+ years of relevant work experience.

*Level will be determined based on skills and related 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.

Requisition Number: 13138BR