Remote Director, Commercial Supply Quality

Definium Therapeutics; United States; Remote; USD 180,000 - 215,000; Full time

Benefits offered by this job

Health benefits

401(k) program with company match

Flexible time off

Equity potential

Job summary

Definium Therapeutics is seeking a Director, Commercial Supply Quality to lead quality for outsourced packaging, labeling, storage, and distribution. You will oversee CMOs/CPOs, 3PLs, and carriers to maintain cGMP compliance and DSCSA standards.

The role requires a decade of GMP QA leadership in commercial supply, with deep experience in packaging, labeling, serialization, and supplier governance across a broad partner network.

Qualifications

• Bachelor’s degree in life sciences, engineering, pharmacy, supply chain, or a related discipline.
• Minimum 10 years of progressive commercial pharmaceutical/biotech GMP quality assurance experience including leadership of commercial supply and cross-functional programs.
• Experience overseeing CMOs, CPOs, 3PLs, distributors, carriers, or other external supply partners.
• Strong working knowledge of pharmaceutical cGMP, packaging/labeling controls, DSCSA, and Good Distribution Practice principles.
• Experience with supplier oversight, quality agreements, audits, CAPA, change control, complaints, and inspection readiness.
• Experience with serialization/traceability platforms or related product-security controls.

Responsibilities

• Provide Quality ownership and leadership for commercial packaging/labeling by CMOs and CPOs from launch to post-approval lifecycle.
• Serve as the Quality relationship owner for packaging/labeling partners with governance and issue escalation.
• Approve packaging artwork/labeling for GMP compliance and change control; Regulatory Affairs approves regulatory content.
• Oversee readiness and lifecycle management for outsourced packaging/labeling, including serialization and line trials.
• Lead quality oversight for storage, transportation, returns, destruction, and distribution in the outsourced network.
• Prepare for launches via 3PL onboarding, lane qualification, returns processing, and traceability data exchange.
• Lead recalls, mock recalls, and DSCSA-related activities; ensure inspection readiness with regulators.
• Establish governance for packaging quality, distribution quality, and product traceability across partners.
• Drive cross-functional collaboration and risk-based decision-making with senior leadership.

Skills

Leadership

External partner oversight

cGMP/DSCSA knowledge

Regulatory readiness

CAPA & change control

Education

Bachelor’s degree in life sciences/engineering/pharmacy/supply chain

Job description

Definium Therapeutics is seeking a Director, Commercial Supply Quality to lead quality for outsourced packaging, labeling, storage, and distribution. You will oversee CMOs/CPOs, 3PLs, and carriers to maintain cGMP compliance and DSCSA standards.

The role requires a decade of GMP QA leadership in commercial supply, with deep experience in packaging, labeling, serialization, and supplier governance across a broad partner network.