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

• Manage and ensure all the activities related to Bioanalytical GLP QA activities are completed as required
• Perform periodic audits of data packages
• Review and approve protocols and reports for GxP studies with an emphasis on GLP studies
• Ensure compliance with applicable regulatory guidelines
• Evaluate studies in determination of root cause and assess quality impact
• Recommend CAPA’s and follow-up to ensure CAPA’s implemented are effective.
• Perform training throughout the organization as needed
• Work with clients and senior management to develop QA project plans
• Participate in regulatory and partner inspections as necessary. Ensure timely follow-up to inspections findings
• Review non-conformance events, log books, procedures, and training as needed
• Write SOPs, reports, and conduct document reviews
• Implement process improvements with senior management
• Use scientific expertise to provide assistance to co-workers and troubleshooting, laboratory investigations, and problem resolution

Qualifications:

• Minimum of 5 years of experience in the Bioanalytical GLP pharmaceutical/biopharmaceutical industry with a minimum of a B.S. Degree
• Previous technical experience in the areas of chemistry, biochemistry, or biology
• Must possess a working knowledge of GLP requirements and other policies/regulations as applicable
• Must possess a conceptual understanding of all Quality functions and business areas
• Must have the ability to function in a fast-paced environment and communicate effectively with senior management