Lead QA Method Validation for Clinical Diagnostics

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

Benefits offered by this job

Performance-based cash incentive

Comprehensive benefits package

401(k) with company contribution

Job summary

Novartis Farmacéutica in Carlsbad, United States, is seeking a skilled professional to lead laboratory method validation. You will play a vital role in ensuring compliance and quality, providing guidance on analytical methods in a regulated environment.

The ideal candidate must have a Bachelor’s degree and at least 8 years experience in GMP laboratory settings, alongside strong analytical, communication, and collaborative skills. The role offers a competitive salary and comprehensive benefits package.

Qualifications

• Minimum 8 years of experience in clinical and/or GMP laboratory environments.
• Experience supporting in vitro diagnostic development.
• Understanding of regulatory requirements and compliance guidelines.

Responsibilities

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

Skills

Quality guidance

Regulatory compliance

Strong communication skills

Statistical analysis

Education

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

Job description

Novartis Farmacéutica in Carlsbad, United States, is seeking a skilled professional to lead laboratory method validation. You will play a vital role in ensuring compliance and quality, providing guidance on analytical methods in a regulated environment.

The ideal candidate must have a Bachelor’s degree and at least 8 years experience in GMP laboratory settings, alongside strong analytical, communication, and collaborative skills. The role offers a competitive salary and comprehensive benefits package.