Senior QA Specialist - GMP Release & Compliance Leader

Gilead Sciences Inc.; Maryland; On-site; USD 124,000 - 160,000; Full time

Job summary

Gilead Sciences Inc. seeks a Senior Quality Assurance Specialist to lead batch record review and release, ensure GMP compliance, and support continuous improvement across manufacturing and quality control data.

You will collaborate with regulatory affairs, internal partners, and external bodies, perform risk assessments, and participate in deviations, CAPAs, and change control to ensure product quality and patient safety.

Qualifications

• Bachelor's degree with 6+ years of experience or
• Master's degree with 4+ years of experience or
• PhD/PharmD with 0+ years of experience.
• Experience with parenteral and aseptic operations; familiarity with Annex 1 requirements.
• Experience across broad QA and/or Quality Systems.
• Experience with interacting with regulatory agencies.

Responsibilities

• Lead batch record review and release activities across manufacturing and QC data.
• Participate in risk assessments and changes to SOPs and controlled documents.
• Support site inspection readiness and internal/external audits.

Skills

Communication skills

Regulatory interaction

Quality mindset

Education

Bachelor's degree

Master's degree

PhD or PharmD

Tools

HACCP

FMEA

Job description

Gilead Sciences Inc. seeks a Senior Quality Assurance Specialist to lead batch record review and release, ensure GMP compliance, and support continuous improvement across manufacturing and quality control data.

You will collaborate with regulatory affairs, internal partners, and external bodies, perform risk assessments, and participate in deviations, CAPAs, and change control to ensure product quality and patient safety.