Manager, Quality Assurance & Compliance

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Overview: Job Description: Experienced quality assurance professional will perform domestic and international GMP, and GCP audits that will assess the company’s compliance to FDA/government regulations, scientific protocols and internal SOPs as they relate to the clinical research process and compliance at Contract Manufacturing Organizations (CMOs). Responsibilities: Job Description: - Manages CMOs to ensure compliance to GMPs and Meda Quality Agreement. Disposition of drug product from CMOs after all batch related documentation has been adequately reviewed. - Develop and execute QA plans to meet regulatory compliance goals - Manage special compliance projects for Corporate Quality Assurance (CQA) GMP, GLP & GCP programs regarding planning, scheduling, conduct, reporting, and evaluation in a matrix environment. - Coordinate and provide oversight to selected individuals designated to provide expertise to special projects. - Conduct audits of clinical and regulatory documents, ensuring the quality, accuracy and completeness of various documents, including but not limited to Clinical Study Reports, Investigator’s Brochures, and Integrated Summaries. - Performance of other quality audits to assess the effectiveness of, and compliance with, policies, processes and procedures and ensuring audits are performed as scheduled. This includes audits of raw material/component vendors, contract manufacturers, internal audits, clinical investigator sites, and computer systems validation. - Must have a thorough understanding of applicable regulations/guidelines to facilitate the interpretation and impact of findings of internal and external audits. - Computer skills and understanding are necessary - Excellent written and verbal communication skills are required - Appropriate technical skills in the compliance disciplines (e.g. GMP, GCP, & GLP) - Be able to interact effectively in a team-based environment Qualifications: Education Requirements: Must have a BS degree in Biology, Chemistry, Pharmacy or a life science Experience/Skills: - 7+ years industry experience and 3+ years auditing experience in the regulatory compliance environment. [Advanced Degree is a plus.] - Must be willing to travel approximately 20 - 25%. - Must have a thorough understanding of applicable regulations/guidelines to facilitate the interpretation and impact of findings of internal and external audits. - Computer skills and understanding are necessary - Excellent written and verbal communication skills are required - Appropriate technical skills in the compliance disciplines (e.g. GMP, GCP, & GLP) - Be able to interact effectively in a team-based environment * Meda Pharmaceuticals Inc. is an Equal Opportunity and Affirmative Action Employer *
Phama Job Categories: 
USA
Quality Assurance

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