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: Organizes investigation activities related to product quality complaints received for commercially distributed and clinical products. Leads or contributes to quality improvement projects within the department. Helps direct the compilation and presentation of complaint data, requesting and tracking investigations from Regeneron CMO and Partner organizations.
Essential Duties and Responsibilities may include, but are not limited to, the following:
• Generate and review investigation reports and data summaries in support of individual complaint investigations.
• Involvement with daily department activities.
• Request investigations from CMO and partner organizations. Monitor progress and coordinate receipt of investigation information.
• Work with Intake/Triage groups to coordinate sample returns analysis and retains examinations.
• Interface with QC for follow up analysis of returned samples.
• Develop and lead continuous improvement initiatives.
• Play a key role in developing corrective and preventative actions.
Knowledge, Skills, and Abilities:
• Excellent written and verbal communication skills with the ability to interact with a broad spectrum of audiences
• Ability to multi-task
• Ability to employ critical thinking
• Ability to anticipate and identify problems and to develop solutions
• Ability to work with ambiguity and drive towards resolution and consensus
Education and Experience:
• Senior Quality Compliance Specialist - BS/BA degree and 5+ years of relevant experience
• Quality Compliance Specialist - BS/BA and 2 - 5 years of relevant experience
• Experience with cGMP principles and Quality Management systems
• Experience with database systems for data mining and software tools (e.g. excel) for performing analysis, Root Cause Analysis tools is a plus.
• Excellent time management and project management skills with the ability to manage many diverse issues simultaneously
• Ability to resolve conflict with tact and diplomacy
• Effectively organize and manage work responsibilities under general guidance
*Level to 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.