Associate Director of Quality Assurance
A company is looking for an Associate Director Of Quality Assurance Clinical Operations.
Key Responsibilities
Provide GXP QA oversight and collaborate with teams and vendors to ensure compliance with project objectives
Develop and implement GXP audit programs and manage quality issues, including root cause assessments
Establish GXP quality metrics and contribute to quality management processes
Qualifications
Bachelor's Degree in life sciences required
Minimum ten (10) years' experience in the biotech or pharma industry, with a focus on biologics and/or gene therapy
Quality assurance experience with clinical research, GCP, GMP, and QA compliance
CQA Certification preferred
Knowledge of FDA regulations, ICH standards, and clinical trial processes
A company is looking for an Associate Director Of Quality Assurance Clinical Operations.
Key Responsibilities
Provide GXP QA oversight and collaborate with teams and vendors to ensure compliance with project objectives
Develop and implement GXP audit programs and manage quality issues, including root cause assessments
Establish GXP quality metrics and contribute to quality management processes
Qualifications
Bachelor's Degree in life sciences required
Minimum ten (10) years' experience in the biotech or pharma industry, with a focus on biologics and/or gene therapy
Quality assurance experience with clinical research, GCP, GMP, and QA compliance
CQA Certification preferred
Knowledge of FDA regulations, ICH standards, and clinical trial processes