Senior QA Lead - GMP Compliance & Regulatory

ALLTECH CONSULTING SVC INC; San Diego (CA); Sur place; USD 100 000 - 120 000; Plein temps

Résumé du poste

A leading consulting firm located in San Diego is looking for a Quality Assurance Senior Specialist to support clinical trial projects. You will ensure compliance with regulatory requirements, lead deviation investigations, and validate testing methods. The ideal candidate has over 10 years of experience in a GMP environment and possesses excellent problem-solving and leadership capabilities. This role requires collaboration with various departments to maintain audit readiness and quality compliance.

Qualifications

• 10+ years of Quality Assurance experience in a GMP manufacturing environment.
• Six Sigma or ASQ certification preferred.
• Ability to provide guidance on quality/compliance concerns.

Responsabilités

• Support clinical trial projects ensuring compliance with regulatory requirements.
• Lead investigations for deviations and complaints.
• Perform document generation and review.

Connaissances

Quality Assurance experience

Problem-solving

Collaboration in a matrix environment

Leadership capabilities

Formation

Bachelors or Master's degree in a scientific discipline

Outils

Six Sigma

ASQ certification

Description du poste

A leading consulting firm located in San Diego is looking for a Quality Assurance Senior Specialist to support clinical trial projects. You will ensure compliance with regulatory requirements, lead deviation investigations, and validate testing methods. The ideal candidate has over 10 years of experience in a GMP environment and possesses excellent problem-solving and leadership capabilities. This role requires collaboration with various departments to maintain audit readiness and quality compliance.