Senior Director, Pharma Supply & Distribution Quality

Jobgether SRL; United States; On-site; USD 180,000 - 215,000; Full time

Benefits offered by this job

100% company-paid medical, dental, and

Job summary

Jobgether SRL, on behalf of a partner company in the United States, seeks a Director of Supply and Distribution Quality to lead GMP quality across an outsourced packaging, labeling, and distribution network. You will drive regulatory readiness, risk-based oversight, and continuous improvement across external partners.

You will manage quality events, CAPAs, serialization, and product-traceability programs, collaborating with cross-functional teams to ensure compliant, secure product supply during

Qualifications

• Bachelor’s degree in life sciences, engineering, pharmacy, supply chain, or related discipline.
• At least 10 years of progressive commercial pharmaceutical or biotechnology GMP Quality Assurance experience.
• Demonstrated leadership of commercial supply, external partner, and cross-functional Quality programs.
• Proven experience overseeing CMOs, CPOs, 3PLs, distributors, carriers, or other external supply partners.
• Strong working knowledge of pharmaceutical cGMP, packaging and labeling controls, commercial distribution Quality systems, DSCSA, and applicable Good Distribution Practice principles.
• Experience with supplier oversight, Quality agreements, audits, quality events, CAPAs, change control, complaints, and regulatory inspection readiness.
• Experience with serialization, traceability-data exchange, suspect-product processes, or related product-security controls.
• Experience making risk-based Quality decisions and influencing senior leaders and external partners without direct operational authority.
• Experience supporting the distribution of controlled substances.
• Strong cross-functional leadership, communication, stakeholder-management, and problem-solving skills.
• Ability to establish effective governance and drive accountability across internal teams and external partners.
• Ability to travel approximately 15%, with periodic increases during launches, significant investigations, partner qualifications, or regulatory inspections.
• Experience with commercial product launches, 3PL implementation, distribution-lane qualification, mock recalls, and initial market supply is preferred.
• Experience with serialization or product-traceability platforms is preferred.
• Experience supporting FDA, state Board of Pharmacy, or other regulatory inspections involving commercial distribution, licensing, packaging, or product traceability is preferred.
• Experience with small-molecule oral solid dosage products is preferred.
• Familiarity with state pharmaceutical licensing, NABP programs, EPCIS, or artwork-management platforms is preferred.

Responsibilities

• Provide Quality leadership and governance for outsourced packaging and labeling activities from launch readiness through lifecycle management.
• Oversee 3PL onboarding, distribution-lane qualification, returns processing, traceability data exchange, mock recalls, and market supply.
• Approve packaging artwork and labeling components from a GMP perspective and coordinate with Regulatory Affairs on regulatory content.
• Lead quality readiness and lifecycle management for outsourced packaging, labeling, serialization, and change control.
• Review final batch and packaging records and make disposition and release-to-market decisions.
• Lead Quality oversight for storage, transportation, returns, destruction, distribution, and reverse-logistics across the outsourced network.
• Establish risk-based oversight of 3PLs, distributors, carriers, depots, storage facilities, and transportation lanes.
• Monitor regulatory requirements and translate changes into procedures and readiness plans.
• Own and continuously improve procedures covering packaging quality, distribution quality, product traceability, and related quality events.
• Represent Quality in external partner meetings and quality components of business reviews.

Skills

Quality leadership

Cross-functional collaboration

Regulatory inspection readiness

Risk-based decision making

Vendor oversight

Project management

Education

Bachelor’s degree in life sciences, engineering, pharmacy, supply chain, or related discipline

Tools

Serialization platforms

Artwork management platforms

Job description

Jobgether SRL, on behalf of a partner company in the United States, seeks a Director of Supply and Distribution Quality to lead GMP quality across an outsourced packaging, labeling, and distribution network. You will drive regulatory readiness, risk-based oversight, and continuous improvement across external partners.

You will manage quality events, CAPAs, serialization, and product-traceability programs, collaborating with cross-functional teams to ensure compliant, secure product supply during