Quality Lead, Biologics & Cell Therapy (GMP/GCP)

R&D Partners; Seattle (WA); On-site; USD 180,000 - 200,000; Full time

Job summary

R&D Partners is seeking a highly motivated Quality Assurance professional to lead quality oversight across early clinical development, manufacturing, and clinical supply activities. You will ensure GMP/GCP compliance and help build a phase-appropriate QMS.

You will oversee vendors, batch disposition, regulatory support for first-in-human programs. Applicants must have legal authorization to work in the United States and a strong background in biopharma QA, with start-up/venture-backed experience

Qualifications

• Bachelor's degree or higher in Life Sciences.
• Extensive QA experience in biopharma.
• Experience managing CRO/CDMO relationships and vendor oversight.
• Strong knowledge of GMP, GCP, FDA, ICH requirements.
• Start-up or venture-backed biotech experience is a plus.

Responsibilities

• Provide end-to-end quality oversight of manufacturing activities, including drug substance and drug product operations conducted at external CDMOs.
• Ensure GMP readiness for clinical supply, including batch record review, deviation management, and lot release activities.
• Partner with CMC and manufacturing teams to support technology transfer and release testing.
• Develop and execute phase-appropriate QMS, SOP management, deviations, CAPAs, and training systems.
• Lead qualification, onboarding, auditing, and ongoing oversight of vendors and contract organizations.
• Support regulatory submissions and interactions with health authorities as required.
• Provide QA oversight for preclinical/IND-enabling activities, including analytical method validation and toxicology studies.
• Embed quality throughout development activities by working cross-functionally with CMC, Clinical, Regulatory, and nonclinical teams.

Skills

Quality Assurance experience

Biopharma

Vendor management

GxP knowledge

Education

Bachelor's degree in Life Sciences

Tools

eQMS / document management

Regulatory documentation systems

Job description

R&D Partners is seeking a highly motivated Quality Assurance professional to lead quality oversight across early clinical development, manufacturing, and clinical supply activities. You will ensure GMP/GCP compliance and help build a phase-appropriate QMS.

You will oversee vendors, batch disposition, regulatory support for first-in-human programs. Applicants must have legal authorization to work in the United States and a strong background in biopharma QA, with start-up/venture-backed experience