Human Genome Sciences (HGS) is a biopharmaceutical company with approximately 800 employees and world-class R&D and manufacturing facilities based in Rockville, MD. We have three promising products in late-stage development – one, raxibacumab, already commercialized with sales to the U.S, Government and two moving toward commercialization. BENLYSTA™ (formerly LymphoStat-B®) has successfully met its primary endpoint in the first of two Phase 3 trials in systemic lupus, and we expect to have results of the second BENLYSTA Phase 3 trial in November 2009. ZALBIN™ (formerly Albuferon®) has completed Phase 3 development in chronic hepatitis C, and we expect the submission of global marketing applications in fall 2009. We are developing both of these products in collaboration with world leaders in the pharmaceutical industry. Further, in July 2009, we secured a new purchase order for 45,000 doses of raxibacumab, a drug to combat inhalational anthrax, to be delivered to the U.S. Strategic National Stockpile over a three-year period. At HGS, people are the key to our success. We share a passion for scientific and business innovation, creating unique opportunities to contribute to the commercialization phase of our products. At HGS, you will have opportunities to learn and grow; interacting with talent of the highest caliber, and you will be supported by a culture committed to employee and leadership development. We offer a competitive salary and benefits package. HGS is an Equal Opportunity Employer EOE/AA M/F/D/V Please visit www.hgsi.com for further information on our company and to apply on-line for this position.  Responsible for assisting in the operation of the clinical quality assurance program at Human Genome Sciences, Inc. to meet applicable regulations and company quality objectives for Good Clinical Practice (GCP).  This position requires an expert understanding of US and international GCP regulations and guidelines especially as they affect the biotechnology industry.  The individual must demonstrate the ability to handle multiple priorities and to interface with various individuals and groups both internal and external to the company.  JOB DUTIES:

Support the development and implementation of GCP quality assurance programs

Plan and perform quality assurance audits of clinical studies sponsored by Human Genome Sciences, Inc. to ensure compliance with GCP

Plan and perform quality assurance audits of associated clinical study information such as clinical databases, clinical and pharmacokinetic study reports, Investigator Brochures

Plan and perform quality assurance audits of associated vendors and contractors

Perform internal audits of drug development departments

Write and report findings for drafting of corrective action and trend analyses.  Follow-up as required on correction issues

Prepare clinical study sites for inspection by FDA and international health authorities

Participate during inspections of HGS as a sponsor of clinical studies

Serve as a company and clinical investigator site resource for GCP information

Design and present employee GCP training

Assist with special QA projects and other duties as assigned.

Bachelor’s Degree in a related science (Biology, Microbiology, Chemistry, etc) or equivalent with a minimum of 7 years-related clinical QA experience, preferably in the pharmaceutical/biotechnology industry

Expert understanding and interpretation of current GCP, especially as related to the biotechnology industry and ability to communicate interpretation to others

Experience in auditing clinical sites for GCP compliance and clinical databases for accuracy and completeness

Expert knowledge of applicable US-FDA regulations and guidelines to include 21 CFR Part 11, ICH guidelines, clinical study operations

Experience with writing, reviewing, and following Standard Operating Procedures

Ability to work within a computerized environment with knowledge of Microsoft Office, clinical databases, e-mail, Internet.

Excellent organizational skills and attention to detail

Excellent oral and written communication skills

Ability to work effectively on a team and strong interpersonal skills