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Miles
Km80.5

Sr. Manager, Clinical Quality Assurance

Millennium: The Takeda Oncology Company

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Location: Cambridge, MA Posted Date: 4/23/2013 Position Type: Full time Job Code: 7283BR Required Education: High school or equivalent

Description

POSITION SUMMARY:

The Senior Manager will be responsible for ensuring that audit plans are developed through discussion with the clinical project teams and then manage the outsourcing of clinical audits of all types. These will include audits of investigator sites, vendors, commercial IRBs, Clinical Study Reports, database, pharmacovigilance, Phase 1 units and other types. The responsibilities include the selection of qualified auditors, the maintenance of the auditor database, and the oversight of these auditors through conducting co-audits and through reviews of audit reports. The Senior Manager will also ensure audit information is included in the Audit Management System and corrective action plans are completed and tracked. The individual will also be responsible for generating Audit Certificates when required.

DUTIES & RESPONSIBILITIES:

Will interact with all the functional groups within the Medical Division and facilitate the identification and implementation of audit plans that require external audit activities. Secondary: The person will also be responsible for setting goals and budgets together with the Director Clinical Quality Assurance for these activities. Dimensions, Scope, Scale: The above responsibilities shall be focused primarily on phase I though IV Clinical Trials and on drug product safety reporting activities (Pharmacovigilance). Contacts & Workflow Participation: Interacts with all the functional groups within the Medical Division; other QA groups; Contract Auditors & CROs

Requirements

QUALIFICATIONS:

BS and 8+ years experience including 2 years auditing experience or MS and 5 years relevant experience including 2 years auditing experience. Other: Sound Awareness and understanding of the Pharmaceutical & Biotech business, especially with regard to the Quality, Compliance and Regulatory Requirements Demonstrated success in auditing and quality improvement processes.
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