Associate Director of Quality Packaging and Labeling Operations

Why Join Us?   Be a hero for our rare disease patients   At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.    Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.   If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

We are seeking a highly motivated Associate Director of Quality Packaging and Labeling Operations with experience in both clinical and commercial packaging, labeling and distribution. The ideal candidate will have experience working with Contract Organizations (COs), good working knowledge of global GxPs supporting clinical and commercial packaging /labeling and distribution. The candidate will work closely with the Technical Operations and Supply Chain teams to independently manage aspects of our global clinical and commercial pack / label contractors and distribution centers. The candidate has a demonstrated ability to drive continuous improvement for pack/label activities across clinical and commercial programs and to establish and maintain Quality Agreements, support deviations and CAPAs, manage complex changes, identify and mitigate inspection risks.

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

 

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.

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 ac