Quality Operations Associate Director

A company is looking for an Associate Director of Quality Operations for a fully remote position. Key Responsibilities Provide GXP QA oversight, including risk assessments and compliance with study protocols and regulatory requirements Collaborate with external vendors and internal teams to ensure project objectives are met in a compliant manner Develop and implement GXP audit programs and manage Significant Quality Issues, including root cause analysis Required Qualifications Minimum of 10 years in biotech or pharma, particularly in biologics/gene therapy Extensive experience in quality assurance, clinical research, GCP, GMP, and QA compliance Proven ability to manage multiple projects in a dynamic environment Preferred CQA Certification and experience with VeevaVault Bachelor's Degree in life sciences is required, preferably with experience in AAV Gene Therapy

Mar 4, 2025 - 21:19

A company is looking for an Associate Director of Quality Operations for a fully remote position. Key Responsibilities Provide GXP QA oversight, including risk assessments and compliance with study protocols and regulatory requirements Collaborate with external vendors and internal teams to ensure project objectives are met in a compliant manner Develop and implement GXP audit programs and manage Significant Quality Issues, including root cause analysis Required Qualifications Minimum of 10 years in biotech or pharma, particularly in biologics/gene therapy Extensive experience in quality assurance, clinical research, GCP, GMP, and QA compliance Proven ability to manage multiple projects in a dynamic environment Preferred CQA Certification and experience with VeevaVault Bachelor's Degree in life sciences is required, preferably with experience in AAV Gene Therapy