Job Description
The QA Manager/Associate Director is mainly responsible for managing the day-to-day activities related to Bioanalytical GLP QA activities.
Duties and Responsibilities
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Manage and ensure all the activities related to Bioanalytical GLP QA activities are completed as required
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Perform periodic audits of data packages
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Review and approve protocols and reports for GxP studies with an emphasis on GLP studies
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Ensure compliance with applicable regulatory guidelines
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Evaluate studies in determination of root cause and assess quality impact
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Recommend CAPA’s and follow-up to ensure CAPA’s implemented are effective.
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Perform training throughout the organization as needed
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Work with clients and senior management to develop QA project plans
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Participate in regulatory and partner inspections as necessary. Ensure timely follow-up to inspections findings
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Review non-conformance events, log books, procedures, and training as needed
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Write SOPs, reports, and conduct document reviews
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Implement process improvements with senior management
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Use scientific expertise to provide assistance to co-workers and troubleshooting, laboratory investigations, and problem resolution
Qualifications:
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Minimum of 5 years of experience in the Bioanalytical GLP pharmaceutical/biopharmaceutical industry with a minimum of a B.S. Degree
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Previous technical experience in the areas of chemistry, biochemistry, or biology
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Must possess a working knowledge of GLP requirements and other policies/regulations as applicable
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Must possess a conceptual understanding of all Quality functions and business areas
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Must have the ability to function in a fast-paced environment and communicate effectively with senior management
