GMP Quality & Validation Consultant - Cell & Gene

Creative Solutions Services, LLC; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Quality Engineering and Validation Consultant to provide expert QA oversight for GMP activities supporting clinical and commercial Drug Product manufacture. This onsite role reports to the Associate Director GMP Quality - Cell & Gene and operates Monday through Friday.

You will lead change controls, validation activities, CAPAs, and risk assessments, ensuring compliance across manufacturing, analytics, materials, and facilities.

Qualifications

• Experience providing QA support and GMP manufacturing oversight.
• Experience leading event investigations and CAPA.
• Strong knowledge of validation, change controls, and risk-based decision making.

Responsibilities

• Provide QA oversight of GMP manufacturing operations and capital projects across development and commercial phases.
• Lead change controls, validation protocols, risk assessments, GMP investigations and CAPAs.
• Identify risks and communicate gaps in GMP processes and systems to drive improvement.
• Review calibrations, PMs, eCRs, work orders and laboratory operations for quality and compliance.
• Support facilities, utilities, and control programs through trending and investigations.

Skills

QA oversight

Aseptic processing

CAPA & investigations

Risk assessment

Validation protocols

Cross-functional collaboration

Quality system knowledge

Education

Master's degree with 3-5 years relevant work experience

Bachelor's degree in engineering/science/health field with 8+ years relevant experience

Tools

Veeva

Nuvolo

Viewlinc

Job description

Creative Solutions Services, LLC is seeking a Quality Engineering and Validation Consultant to provide expert QA oversight for GMP activities supporting clinical and commercial Drug Product manufacture. This onsite role reports to the Associate Director GMP Quality - Cell & Gene and operates Monday through Friday.

You will lead change controls, validation activities, CAPAs, and risk assessments, ensuring compliance across manufacturing, analytics, materials, and facilities.