biogen idec - Sr Manager, Drug Compliance Job in Cambridge 02142, Massachusetts US
Job TitleSr Manager, Drug ComplianceLocationCambridge,MARequisition Number11347BRJob Description-Provides Quality evaluations, recommendations, advice and support to management on Pre-clinical and Clinical drug development activities.
-Manages third party contractors and external consultants.
-Oversees the monitoring/auditing of Contract Research Organizations (CROs) and laboratories.
-Collaborate with internal customers to provide GCP guidance,-Participate in regulatory inspections, -Manage internal and external auditors,-Provide development plans and evaluate performance-Provide training and mentoring to junior auditors,-Develop and manage project/study audit plans.
-Direct the development of systems for measuring compliance with the companys GCP/GLP quality goals, objectives and standards.
-Direct the company's internal and external quality system audits including investigations/deviations-Provide input into the development, improvement, validation, and quality systems.
-Conduct reviews of Protocols, Test Plans, and Amendments for Method Validation, activities.
-Conduct in-process audits on critical phases of GLP studies or analyses.
-Perform audits of study data and documentation, and final reports.
-Conduct audits on internal systems such as equipment maintenance and qualification, sample receipt, training files, and receipt of raw materials.
-Generate QA reports for audits, study phase inspected and follow up on audit observations to assure appropriate resolution.
-Conduct close-out meetings with study directors/principal investigators after each audit.
-Issue QA statements for all GLP studies.
-Maintain validation and GLP Study master schedules.
-External study responsibilities: -Perform GLP vendor site qualification audits, follow-up visits, and routine requalification inspections as needed.
-Review of protocols, amendments, and study reports.
-Domestic and international travel required (~15%)QualificationsoBS Degree in Biology, Chemistry or other Science and 10 years of relevant GLP and/or GCP experienceoMust have 5 or more years of experiencing managing direct reportsoPrior experience auditing in a pharmaceutical/biotech research and development environmentoStrong working knowledge of ICH, FDA 21 CFR Part, 11, 58 and 312 oAbility to manage, lead, mentor and train subordinates.
oMust have strong diplomatic and negotiation skills supported with excellent oral and written communication skills.
About Biogen Idec: Transforming Discovery into Care With operations across the Americas, Europe, and Asia, Biogen Idec (NASDAQ: BIIB) is one of the world's leading biotechnology companies, creating new standards of care in oncology, neurology, and immunology.
Every day, employees of Biogen Idec make a difference in people's lives, through pioneering research and development, manufacturing, and our worldwide commercial capabilities.
Learn more at www.biogenidec.com/careers .
Biogen Idec is proud to be an equal opportunity employer
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