Senior QA Method Validation Lead - GMP/Diagnostics

Novartis Group Companies; Carlsbad (CA); On-site; USD 114,100 - 211,900; Full time

Benefits offered by this job

401(k) with company contribution

Performance-based cash incentive

Comprehensive benefits package

Job summary

Novartis Group Companies in Carlsbad, California, seeks a Quality Leader to manage laboratory method validation critical to breakthrough therapies. You will work in a highly regulated environment and ensure compliance with quality and scientific standards.

The role demands a Bachelor’s degree and significant industry experience, focusing on in vitro diagnostics, risk assessments, and audits. The compensation is competitive, with a salary range of $114,100 - $211,900 annually along with comprehensive benefits.

Qualifications

• Minimum of 8 years’ experience in clinical and/or GMP laboratory environments.
• At least 3 years experience supporting in vitro diagnostic development.
• Understanding regulatory and compliance requirements (GxP, ICH, ISO, etc.).

Responsibilities

• Lead review and approval of method validation protocols.
• Provide quality guidance on analytical method validations.
• Ensure adherence to regulatory and company requirements.

Skills

Collaboration

Communication Skills

Data Integrity

Decision Making

Digital saviness

Leadership

Managing Ambiguity

Organizational Saviness

Regulatory Requirements knowledge

Risk Management

Education

Bachelor’s degree in engineering, medical technology, biological sciences, or related field

Job description

Novartis Group Companies in Carlsbad, California, seeks a Quality Leader to manage laboratory method validation critical to breakthrough therapies. You will work in a highly regulated environment and ensure compliance with quality and scientific standards.

The role demands a Bachelor’s degree and significant industry experience, focusing on in vitro diagnostics, risk assessments, and audits. The compensation is competitive, with a salary range of $114,100 - $211,900 annually along with comprehensive benefits.