Senior Director, Quality Assurance & CDMO Oversight

Attovia Therapeutics; San Carlos (CA); On-site; USD 180,000 - 280,000; Full time

Job summary

Attovia Therapeutics seeks a Sr./Director of Quality Assurance to lead the QA function and oversee external CDMO/CRO partners handling GMP manufacturing, testing, and clinical activities. You will ensure the QMS integration across outsourced work, enabling inspection-ready compliance and patient safety.

You will collaborate with CMC, Clinical Ops, and Regulatory Affairs to align vendor oversight, CAPAs, deviations, and change controls, while driving a proactive quality culture at a growing

Qualifications

• 12+ years of Quality Assurance experience in biotech/pharma.
• Direct experience managing outsourced GMP manufacturing/testing (CDMO) relationships.
• Strong knowledge of FDA/EMA/ICH and GCP/GLP regulations.
• Experience auditing contract manufacturers, labs, CROs; negotiating Quality Agreements.
• Experience reviewing batch records, CoAs, deviations, change controls.

Responsibilities

• Own quality oversight of CDMO activities ensuring regulatory compliance.
• Review and approve CDMO batch records, protocols, and QC documentation.
• Drive risk-based oversight of CDMO quality systems including CAPAs and deviations.
• Support technology transfer and process validation at CDMO sites.
• Provide GCP/GLP quality oversight of CROs supporting trials and nonclinical studies.
• Lead vendor qualification, audits, and Quality Agreements; maintain vendor list.

Skills

Leadership

Quality strategy

Regulatory knowledge

Risk assessment

Communication

Independent work

Education

Bachelor's or Master's degree in Life Sciences or related

Tools

Veeva QMS

MasterControl

TrackWise

Job description

Attovia Therapeutics seeks a Sr./Director of Quality Assurance to lead the QA function and oversee external CDMO/CRO partners handling GMP manufacturing, testing, and clinical activities. You will ensure the QMS integration across outsourced work, enabling inspection-ready compliance and patient safety.

You will collaborate with CMC, Clinical Ops, and Regulatory Affairs to align vendor oversight, CAPAs, deviations, and change controls, while driving a proactive quality culture at a growing