Associate Director of Quality Packaging and Labeling Operations

Associate Director of Quality Packaging and Labeling Operations

Requirements

• Bachelor’s degree preferably in a scientific discipline.
• 7+ years’ of experience working in a CBER / CDER regulated industry GxP regulated industry.
• Strong working knowledge and interpretation of FDA/EU and ICH – GxP regulations and guidelines.
• Capability of collaboratively engaging with Contract Organizations.
• Experienced in all phases of biologic and small molecule drug development. Gene therapy experience is desired.
• Strong background in negotiation of Quality Agreements with COs.
• Strong experience with Commercial Supply Chain including orphan drug distribution channels, early access programs, and partner management.
• Fosters an environment of accountability, diversity and speaking up.
• Ability to interpret and relate Quality standards for implementation and review.
• Experience with GDP/GMP auditing practices.
• Strong experience with regulatory authority inspections, including both FDA and EMA.
• Ability to produce quality results across multiple projects and prioritize demands.
• Strong teamwork, interpersonal skills and negotiation skills, both internally and externally.
• 20% travel (some international required).

Responsibilities

• Provide operational support for pack/label activities across clinical and commercial programs.
• Negotiate, implement, and manage quality agreements with pack/label and distribution contract organizations.
• Support review of clinical and commercial label text, label proofs, and label specifications.
• Support review of distribution protocols for Contract Distribution providers in accordance with SOPs.
• Prepare and support Quality Quarterly Business Review metrics for Supply Chain Contract Organizations.
• Ensure quality of products produced / maintained at contractors through review of batch production records.
• Perform assessments for change controls within electronic document management systems.
• Review and approve deviations and discrepancies at COs to assess product quality impact. Monitor effective checks of CAPAs.
• May function as Person-in-the-Plant (PIP) at CO sites. This position may also assist in the auditing of contract pack / label sites and distribution centers.
• Collaborate with business partners and GMP / GDP-regulated vendors to ensure successful planning, execution and delivery of projects.
• Ensure activities and deliverables are in compliance with FDA, EMA and local regulations and guidance, ICH guidelines, Ultragenyx’ policies, SOP’s and best practices.
• Support the Tech Ops team in Supply Chain risk assessment and Shipping Validation.
• Identify and drive improvements within the Supply Chain QA team.
• Other duties as assigned.

Preferred Qualifications

• Gene therapy experience is desired.