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Director, Supply and Distribution Quality

41 minutes ago
Anywhere
Full-time
Executive
Operations Manager
Quality Assurance and Testing
Git
Apply Now
Definium Therapeutics

Definium Therapeutics

Definium Therapeutics is dedicated to advancing psychiatry by developing accessible treatments that leverage the therapeutic potential of psychedelic medicine, guided by scientific rigor and a commitment to addressing the root causes of mental health i...

Health Care Providers & Services
51-250
Founded 2019
View All Jobs 6

Description

  • Lead Quality oversight for outsourced commercial packaging and labeling from launch readiness through lifecycle management.
  • Own quality relationships with CMOs, CPOs, 3PLs, distributors, carriers, and related technology providers.
  • Review packaging and labeling artwork, batch records, packaging records, and final batch dispositions.
  • Lead quality readiness for 3PL onboarding, distribution-lane qualification, returns, mock recalls, traceability-data exchange, and initial market supply.
  • Establish risk-based oversight for storage, transportation, distribution partners, facilities, equipment, and supporting systems.
  • Manage logistics quality events, including temperature excursions, damage, loss, theft, diversion, security events, and delivery exceptions.
  • Lead the DSCSA quality compliance program, including serialization, verification, transaction-data exchange, exception management, and record retention.
  • Oversee suspect and illegitimate product investigations, recalls, distribution holds, market actions, returns, and resulting dispositions.
  • Own and improve quality procedures, partner governance, quality agreements, performance monitoring, CAPAs, and inspection readiness.
  • Set functional strategy and performance indicators while reporting commercial supply quality risks and trends to senior leadership.‌

Requirements

  • Bachelor’s degree in life sciences, engineering, pharmacy, supply chain, or a related discipline.
  • At least 10 years of progressive commercial pharmaceutical or biotechnology GMP Quality Assurance experience, including leadership of commercial supply and external-partner programs.
  • Experience overseeing CMOs, CPOs, 3PLs, distributors, carriers, or other external supply partners.
  • Strong knowledge of pharmaceutical cGMP, packaging and labeling controls, distribution quality systems, DSCSA, and Good Distribution Practice principles.
  • Experience with supplier oversight, quality agreements, audits, quality events, CAPA, change control, complaints, and inspection readiness.
  • Experience with serialization, traceability-data exchange, suspect-product processes, or product-security controls.
  • Ability to make risk-based Quality decisions and influence senior leaders and external partners without direct authority.
  • Experience distributing controlled substances.
  • Ability to travel approximately 15%, with increased travel possible during launches, investigations, partner qualifications, or inspections.
  • Preferred experience with commercial launches, 3PL implementation, distribution-lane qualification, mock recalls, FDA or Board of Pharmacy inspections, oral solid dosage products, NABP programs, EPCIS, or artwork-management platforms.

Benefits

  • Base salary of $180,000–$215,000, with compensation based on experience, skills, and location.
  • Potential bonus and equity compensation.
  • 100% company-paid medical, dental, and vision coverage for employees and dependents.
  • 401(k) program with company match and early vesting.
  • Flexible time off.
  • Generous parental leave and additional fringe perks.

Interested in this position?

Apply directly on the company website

Apply Now

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