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Quality Assurance Manager

4 months ago


Los Angeles, United States Comrise Full time

Quality Assurance Manager Location: San Diego 92131, Hybrid(2-3 days onsite)

MAJOR RESPONSIBILITIES AND DUTIES: • Participate in the development and maintenance of an effective Quality Management System to include the development, maintenance, and management of company policies, SOPs and associated processes and procedures; this will include a “needs assessment” of company policies and procedures. • Take a lead role in the management of the company’s GCP training program and other required clinical quality assurance-based training. Maintain records of employee training on policies, SOPs, and associated processes and procedures. • Take a lead role in the development and maintenance of a document control system to ensure the company’s document change-control processes are consistent with industry best practices. • Develop and maintain a Vendor Management System to include tracking tools to help ensure that the company’s vendors are appropriately qualified and/or requalified, as appropriate. Perform systems- and process audits of vendors, as directed. • Conduct internal and external audits of drug development-related study records to ensure compliance with regulatory requirements and company SOPs. • Participate in preparations for regulatory inspections/mock regulatory inspections. • Perform quality assurance reviews of clinical documents to include protocols, Informed Consents, Investigator Brochures, Trial Master Files, and clinical labels. • Take a lead role in developing and maintaining a Nonconformance (deviation) Management System to include appropriate documentation, investigations, and tracking of SOP and/or protocol deviations, corrective and preventative actions (CAPAs), and their resolution. • Assist with the preparation and submission of regulatory documents including but not limited to correspondence, briefing documents, INDs/NDA applications, and amendments/supplements. • Provide input to clinical functions to ensure that clinical trial activities are conducted by CROs in compliance with GCP guidelines, applicable legislation, and internal requirements. • Participate in the development of QA strategies for projects and programs. • Provide support for business development activities as directed. • Assist with non-clinical pharmacology, toxicology, and chemistry manufacturing and control (CMC) study quality-assurance activities. • Apply critical thinking and problem-solving skills to identify potential compliance issues and offer solutions. • Collaborate with functional teams to provide quality guidance and assistance with the development of documents and processes using risk management principles.

Qualifications: • Bachelor's degree or equivalent experience in Medicine or related field • 5+ years' relevant work experience • Highly organized with excellent attention to detail • Native-level proficiency in English and Mandarin

Salary: $100K/ - $120K/annual

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