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Senior Audit Manager

Company: Meet
Location: San Francisco
Posted on: January 17, 2020

Job Description:

Auditor - R&D Compliance - Remote - San Francisco North Bay Our client, a San Francisco Bay Area Biotech company, has partnered with us to locate R&D Compliance Auditor. This role would be in the North San Francisco Bay Area or remote. This individual will play a significant role in the GCP, GLP and GVP audit program. The role will involve planning /executing domestic and international audits to assess compliance with international regulations, I.E FDA, EMA, MHRA, Asia Pacific & Latin America. RESPONSIBILITIES --- Independently lead audits domestically and internationally to evaluate audit QMS and assess compliance with regulatory standards and data integrity. --- Assure audit reports are authored and distributed. --- Communicate audit outcomes and observations to internal management. --- Review and approval of CAPA's . --- Communicate significant information regarding quality and patient safety risks to upper Management and major stakeholders. COMPETENCIES --- 10+ years of experience in the Pharma, Biotech or Medical Device industry within GVP- - - - - GLP-GCP, - QA auditing/Regulatory Compliance or equivalent. --- Up to date competency of international GCP, GCLP, GLP & GVP regulations. Along with - - - - the - following guidelines FDA, EMA, MHRA, ICH & OECD. --- Ability to participate in a team-oriented environment. --- Desire and skill to coach, lead & motivate a specialized Compliance team.

Keywords: Meet, San Francisco , Senior Audit Manager, Executive , San Francisco, California

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