A biopharmaceutical company is seeking an Associate Director, Quality Operations to provide QA support for its Biologics programs. The ideal candidate has a minimum of 10 years experience in GMP Quality Control and has demonstrated excellent communication skills. Responsibilities include quality oversight of contract laboratories and maintaining compliant data integrity practices. This role requires travel approximately 10-20% of the time.
Qualifications
Minimum of 10 years’ experience in GMP Quality Control/Quality Assurance.
Experience with data integrity assessments or remediation.
Knowledge of global regulations for manufacturing and testing.
Responsibilities
Quality oversight of contract laboratories.
Review testing execution by CDMOs.
Maintain compliant data integrity practices.
Skills
GMP Quality Control
Data integrity assessments
Analytical support
QC support
Microbiology
Excellent communication
Education
Bachelor’s Degree in a scientific discipline
Job description
A biopharmaceutical company is seeking an Associate Director, Quality Operations to provide QA support for its Biologics programs. The ideal candidate has a minimum of 10 years experience in GMP Quality Control and has demonstrated excellent communication skills. Responsibilities include quality oversight of contract laboratories and maintaining compliant data integrity practices. This role requires travel approximately 10-20% of the time.