Alexion Pharmaceuticals, Inc.
The Associate Director, GCP Audit Lead (US) is responsible for the management of the GCP audit program in the United States, including clinical investigator site, external services provider and internal process audits. The GCP Audit Lead (US) is based in Boston. The GCP Audit Lead (US) contributes to the development of the R&D Master Audit Plan, using risk based methodology and assures adherence to it. The GCP Audit Lead is responsible for performing audits to meet the needs of the business. In addition, the position is responsible for the oversight of regionally selected audit vendors, and ensures that the vendors are trained, follow Alexion audit practices and deliver quality audits. The GCP Audit Lead also supports GxP inspection management activities as required.
Contributes to the overarching GxP audit program through risk-based analysis, understanding of the clinical development portfolio and vendor programs.
Executes against the Master Audit Plan with responsibility for the United States as well as assigned assets.
Selects, contracts and onboards GCP vendors, assuring quality of deliverables through active oversight.
Contributes to audit process improvement efforts to assure an efficient, compliant and effective audit program, ensuring consistency of approach with other auditing teams.
Performs high risk and GCP critically sensitive audits.
Performs peer review of audit reports assuring quality of reports, consistency in documentation and appropriateness of findings classification.
Partners with the RDQ Systems and Processes group to deliver metrics, assess trends and generate governance reports.
Supports GxP inspections when necessary, either in front or backroom management to assure a well-run inspection.
Minimum 10 years’ pharmaceutical or biotechnology industry experience performing audits
Experience overseeing contractors
GCP expertise is required
Bachelor’s Degree in Business or Life sciences is required, advance degree is preferred
Boston, MA, United States
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer
Apply for this job at https://alexion.contacthr.com/60510131
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Alexion Pharmaceuticals, Inc.
Website : http://www.alexion.com
Alexion Pharmaceuticals, Inc. is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with severe and life-threatening diseases that are also ultra-rare. Patients with these devastating diseases often have no effective treatment options, and they and their families suffer with little hope.