Sr Quality Compliance Specialist (Product Quality)

Rensselaer, NY, United States
Mar 12, 2019
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 the coordination and assurance of timely commercial and clinical product supply through the preparation of documentation packages and comprehensive review of product documentation for product release.

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

• Manage the proactive coordination of the receipt of documentation deliverables from cross-functional responsible parties in a timely manner to ensure continued product supply.

• Maintain accurate tracking spreadsheets and databases detailing work statuses. Information is used to assess drug supply position.

• Foster communication with key stakeholders in order to properly plan and prioritize workloads based on potential impact to clinical study and commercial supply.

• Serve as primary quality contact for Regeneron IOPs and the distribution vendors for qualified person certification.

• Review batch records, specifications, SOPs, data, and other supporting documentation related to the manufacturing, testing, packaging, and labeling processes to assess compliance with the regulatory submissions.

• Collaborate with cross-functional departments to resolve discrepancies and ensure compliance.

• Identify and implement continuous improvement initiatives.

• Support QA project initiatives for a broad range of topics as the Product Quality group evolves.

• Perform other support responsibilities as requested.

Knowledge, Skills, and Abilities:

• Comprehension of quality and cGMP principles and relevant global regulatory guidelines.

• Strong attention to detail.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

• Demonstrated flexibility in responding to changing priorities and unexpected events while achieving high quality, compliant deliverables.

• Proactive with proven ability to work under own initiative to accomplish objectives and timelines.

• Strong interpersonal, written, and oral communication skills to communicate effectively.

• Ability to manage conflict with tact and diplomacy.

Education and Experience:

• Requires BA/BS (engineering, scientific or related field preferred) and 5+ years of related experience working in a cGMP environment or in the operation of a relevant industrial facility; or equivalent combination of education and 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.