Quality Assurance Operations Lead, Biopharma Manufacturing

Regulatory Jobs; Carlsbad (CA); On-site; USD 59,000 - 110,000; Full time

Job summary

Novartis in Carlsbad, California seeks a QA Operations Specialist to support manufacturing excellence, safeguard product quality, and drive site-wide compliance. You will collaborate with cross-functional teams to bring innovative therapies to patients and foster a culture of continuous improvement and quality leadership in a fast-paced environment.

The role includes a 12-hour rotating shift schedule, with specific days and overtime as needed, plus responsibilities such as batch record review,

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, or a related field.
• Minimum 3 years of experience in GxP biopharmaceutical or API manufacturing operations.
• Minimum 2 years of experience in a Quality Assurance role within a regulated environment.
• Quality Assurance or Quality Control experience in pharmaceutical environments with environmental monitoring and cleanliness zones.
• Experience reviewing quality documentation and supporting compliance within manufacturing operations.
• Experience supporting regulatory inspections, continuous improvement initiatives, or operational excellence projects.

Responsibilities

• Provide Quality Assurance support for manufacturing, quality control, engineering, and supply chain operations.
• Review and approve test records for batch release, SOPs, CAPAs, Deviations, OOX investigations, Quality Risk Assessments, Quality Plans/Events, protocols, and change controls.
• Perform shop floor oversight and provide compliance guidance supporting operational decision-making.
• Conduct live batch record review and execute acceptable quality limit inspections.
• Support continuous quality improvement initiatives that enhance manufacturing quality, compliance, and operational efficiency.
• Support regulatory inspection readiness, execute inspection activities, and maintain ongoing site CGMP compliance.

Skills

Collaboration

Data Integrity

Leadership

Operational Excellence

Education

Bachelor’s degree in Life Sciences, Chemistry, or related field

Job description

Novartis in Carlsbad, California seeks a QA Operations Specialist to support manufacturing excellence, safeguard product quality, and drive site-wide compliance. You will collaborate with cross-functional teams to bring innovative therapies to patients and foster a culture of continuous improvement and quality leadership in a fast-paced environment.

The role includes a 12-hour rotating shift schedule, with specific days and overtime as needed, plus responsibilities such as batch record review,