Sr. / Principal QA Auditor (GCP Auditing) - Remote

Location
Tarrytown, New York, US
Posted
Nov 20, 2018
Ref
14797BR
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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. SUMMARY . This position will be responsible for planning and conducting GCP audits vendor, internal process and investigator site and may include responsibilities for providing Quality Assurance support to clinical operations. JOB RESPONSIBILITIES . Schedule, prepare and conduct audits in support of GCP as directed . May assemble and coordinate the activities of the audit team . Conducts audits in accordance with Regeneron standard operating procedures and quality policies . May provide Quality Assurance support and guidance to clinical operations . May be responsible for QAA projects associated with developing and managing risk assessments, CAPA, metrics, etc . May be responsible for gathering and interpreting regulatory intelligence, as well as evaluating internal practices, making recommendations for improvement, and executing against action plans . Interprets policies, standards, and regulations, and evaluates potentially critical problems not covered by policies, standards, and regulations . Exercises judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, and protocols for compliance . Appropriately escalate any compliance issues . May be involved in the investigations of suspected serious noncompliance . Communicates audit results to management and auditees through written audit reports . Manage post-audit activities and follow-up on any necessary corrective and preventive actions . resolves any conflicts . May assist with supporting regulatory facility inspections . May draft and issue periodic reports to site management as requested . May be involved in identifying and developing continuous improvement efforts . May assist with training/orientation of new QAA staff . EXPERIENCE AND REQUIRED SKILLS . BS/BA with 5+ years of related experience in Biotech/Pharmaceutical industry required additional relevant experience may be considered in lieu of degree . Minimum of 2 years of direct audit experience in GCP required Level will be determined based on skills and experience relevant to the role. 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, disability status, protected veteran status, or any other characteristic protected by law #LI-DF1