Sr. Quality Manager, GCP


Boston, MA

What you'll be doing

Responsible for developing a strategic audit plan for the development of assigned compounds and ensuring that audits are conducted in accordance with the plan according to the audit process as per and standards operating procedures (sops) and processes. Leads domestic and international audits for clinical investigators and acts as the lead auditor vendor audits, internal process audits and/or GCP document audits to ensure compliance to the code of federal regulations, the international conference of harmonization (ICH), applicable regulations and laws and sops. Leads or participates as a co-auditor for investigations into scientific misconduct and/or serious breach of GCP, analyzes investigational findings to identify root cause. Oversees appropriate corrective actions and preventive actions (CAPAS). Assures reporting of potential or confirmed violations, as appropriate, in accordance with sops and processes. Promotes consistency of audit report writing. Identifies and escalates critical quality issues appropriately to senior QA management. Obtains audit responses from functional areas or vendors and evaluate proposed CAPAS for adequacy if implemented successfully in accordance with sops. Ensures adequate and timely closure of CAPAS with supporting documented evidence in accordance with sops and processes. Contributes to the development of continuous quality process improvements. Maintains and reports accurate and timely metrics associated with assigned compound or clinical development program as assigned. Provides inspectional support for regulatory inspections held at facilities or clinical investigator sites as needed. Maintains current training in accordance with the QA GCP training curriculum.

What your background should be

Minimum 4-9+ years or relevant GCP experience or relevant comparable background and 5 + years of relevant QA experience. Advanced knowledge of FDA regulations, EU directives, MHRA statutory instruments and ICH guidance. Understands the clinical development phases of drug development. Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers. Must be able to organize and prioritize work effectively to meet timelines with quality deliverables. Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building. Understands the medical/therapeutic impact of investigational products. Proficiency in using Microsoft office applications is an asset (MS Word, MS Excel, MS PowerPoint).

Required Schooling / Training

Bachelor/master degree in a scientific or allied health field.

Who is the client company

This is a staffing expertise company and its global recruiting team ensures speed of delivery and low-cost service.
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