Senior R&D Quality Lead for GMP & Clinical Supply

AbbVie; California (MO); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Job summary

AbbVie in the United States is seeking a Senior R&D Quality Officer to perform GMP batch documentation review and clinical supply disposition for NBE, NCE, and ATMP programs. You will apply QA expertise to ensure compliance across TPMs and AbbVie sites and mentor junior staff.

Responsibilities include leading deviations, CAPA, risk-based assessments, and quality system maintenance, while partnering with Clinical Drug Supply Management and Operations to safeguard batch availability and supply

Qualifications

• Bachelor's degree in Biology, Chemistry, Biochemistry, Pharmacy, or Chemical Engineering.
• 4–6 years of QA in pharma/biotech; 8+ years preferred, with GMP experience.
• Knowledge of global GMP requirements for biologics, small molecules, and ATMPs.
• Experience reviewing GMP batch records and quality documentation; strong documentation skills.
• Ability to manage multiple priorities in a fast-paced development environment.

Responsibilities

• Review and approve GMP batch records and quality documentation for clinical supply batches.
• Lead deviation investigations, CAPA plans, and root cause analysis.
• Disposition batches and ensure batch release decisions per SOPs and GMP.
• Develop and maintain quality system documents and SOPs.
• Support TPM and supplier quality oversight, including escalation and qualification discussions.
• Ensure inspection readiness and participate in mock audits.
• Mentor and train junior PDQA staff and cross-functional partners.

Skills

Quality Assurance

GMP compliance

Batch records

Risk assessment

Supplier quality

Quality systems

Cross-functional collaboration

Education

Bachelor’s degree in Biology/ Chemistry/ Biochemistry/ Pharmacy

MS/PhD preferred

Tools

Electronic batch records (eBR)

Quality Management Systems (QMS)

ICH Q7/Q10 knowledge

Job description

AbbVie in the United States is seeking a Senior R&D Quality Officer to perform GMP batch documentation review and clinical supply disposition for NBE, NCE, and ATMP programs. You will apply QA expertise to ensure compliance across TPMs and AbbVie sites and mentor junior staff.

Responsibilities include leading deviations, CAPA, risk-based assessments, and quality system maintenance, while partnering with Clinical Drug Supply Management and Operations to safeguard batch availability and supply