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QA Manager

QA Manager

A leading drug discovery and development company is looking for a QA Manager. The primary responsibility will be to assure compliance and quality of preclinical development studies. Duties include planning and executing audits of on-going preclinical studies, analyzing processes, systems and data flows and auditing finished study reports. This position will also have opportunity to participate in the assurance of quality of our clinical projects. The incumbent will provide risk analysis and develop solutions to a variety of complex problems.

Major Areas of Responsibility:

• Assure the quality of our non-clinical development activities.
• Plan and conduct audits of preclinical development partners.
• Participate in the approval of preclinical sites selected for the studies.
• Participate in risk assessment and risk mitigation of preclinical development projects.
• Anticipate and prevent problems; identify alternatives and solutions.
• Drive implementation of new company initiatives in terms of quality assurance and compliance with emerging national and international guidelines and regulations
• Ensure that all work is performed adherence to relevant protocols, SOPs, and ICH/GLP and GMP guidelines.
• Assist in clinical site and process audits.

Excellent salary and benefits package offered.

Job Requirements

• Must have at least a B.S. degree and 5 years in the pharmaceutical industry with Quality Assurance responsibilities.
• Qualified candidates will have knowledge and proficiency in ICH guidelines and FDA and international regulations relating to GLPs.
• Must have experience with process analysis, auditing vendors and study reports, and assessing capabilities of potential preclinical development partners from a quality and compliance perspective are essential.
• Experience with GCPs is considered a plus.
• The ability to manage multiple projects simultaneously with aggressive timelines at a high level of productivity should be demonstrated.

For immediate consideration, please forward a copy of your current resume to info@profrecruiters.com referencing job # or a link to this job.

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