Senior GMP Auditor - Remote opportunity

Rensselaer, New York, US
Sep 23, 2018
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 planning, coordinating and performing pre-, during and post-audit activities for assigned audits. Responsible for assessing systems, processes, procedures and records against applicable U.S. and ex-U.S. GxP regulations, with primary emphasis on GMP, IT and Quality audits that may impact Regeneron operations and/or product.

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

• Maintain professional expertise and knowledge of audit criteria including, but not limited to, internal company policies and procedures, and applicable local and international regulations, standards and guidelines (e.g., Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, and ICH, WHO and IPEC Guidelines, etc.);

• Monitor industry trends with respect to regulatory agency findings, expectations and warning letters;

• Perform supplier/external audits and evaluate systems, processes, procedures and records against applicable U.S. and ex-U.S. audit criteria as stated above;

• Collaborate with Procurement, External Manufacturing, Quality, audit clients and other stakeholders with respect to supplier/external audits;

• Perform all audit activities for assigned audits when acting as lead auditor; lead and coordinator all audit activities and the audit team when assigned as the lead auditor on an audit team;

• Support the lead auditor in all audit activities when assigned as a support auditor on an audit team;

• Ensure written and departmental procedures, timelines and requirements are followed and met;

• Prepare written audit documents and reports; ensure the quality and accuracy of all audit documentation;

• Provide guidance and support in the development of both corrective and preventive actions based on GxP requirements and industry standards;

• Perform peer reviews of audit documentation and auditee responses; ensure requirements for audit documentation and auditee responses are met;

• Participate in IOPS inspection readiness and inspections/partner audits, as needed;

• Perform and/or host internal audits of Regeneron IOPS facilities, as needed;

• Assist with the oversight, selection, training, onboarding and/or consultant auditor performance assessments, as assigned by management;

• Participate in new employee orientation and perform and maintain all required training and annual GMP training within required timelines; and

• Assist with training and qualification of auditors, as assigned by management.

• Assist management with training auditors to assess the acceptability of auditee response and ensuring audit findings are classified appropriately, as assigned.

**This position requires approximately 50% travel.**
Education and Experience:

• BS/BA with 5+ years of related experience in Biotech/Pharmaceutical industry; other relevant experience may be considered in lieu of degree.

• 5+ years of audit experience in GMP environment; experience in aseptic filling operations preferred.

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.