Associate Director Quality Assurance Salary in the United States

Change location

Provides Quality input for functional groups responsible for Six Sigma initiatives Contribute to process improvement initiatives across organization Ensure the successful and timely execution and participation in audits, as assigned, according to applicable SOP(s) and the Quality Audit Schedule Provide guidance to auditors regarding quality issues relating to the Quality Audit Schedule Identify non-conformances with requirements and provide suitable recommendations Ensure that audit reports are completed in a timely manner and that audit results are communicated to auditees and management Ensure suitable responses and action plans are provided by auditees Escalate to management where resolution of audit findings are inadequate Prepare and ensure executive summaries of audit findings and trending are delivered to management Serve as a backup auditor to other Global QA staff when applicable.

Lead, and/or conduct/support (in collaboration with GMP QA colleagues), global Good Pharmacovigilance Practice (GVP) Audits of systems and processes related to clinical and post-market patient safety information collection, evaluation and reporting.

Support process transfer and process engineering of retroviral replicating vectors (RRV) platform products including process optimization, new product implementation, process transfer, scale-up, validation, risk analysis process characterization and troubleshooting.

Development of short and long-term risk-based quality strategies in support of M&D development programs based on current regulatory interpretations, and drives their implementation locally and globally as appropriate.

Manage batch release activities for clinical production including but not limited to review of batch records, analytical data with emphasis on the effect of safety and/or efficacy impact to the clinical study, certificates of analysis, evaluation of the IND and other documents.

Review and approve SOPs, Mater Batch Records, test methods, test results, labeling materials, specifications, analytical validation protocols and reports, and stability protocols and reports and associated records/data.

Assistant Directors of Enrollment Services, and the Assistant Directors of Student Recruitment and/or Enrollment are educated and trained properly to create the best prospective learner service possible and to ensure that the team is equipped with the processes and knowledge to increase efficiency through the sales cycle.

Participate in the development of internal and external GLC/GCP/GVP annual audit plan for sites and vendors and update the audit plan as needed based on identified risks and trial priorities.

Collaborate with Commercial, IT, Clinical Operations and Supply Chain to execute and improve processes that include the interlinked process elements of patient identification, treatment regimen and logistics.

Demonstrated ability to apply comprehensive, in-depth, understanding of pharmaceutical industry regulatory compliance requirements with an emphasis on GMP/GLP/GCP related issues, and related US and international laws.