Position Summary :
ultrafocused - Work together to fearlessly uncover new possibilities
We are seeking a highly motivated QA Supply Chain Associate Director with experience in both clinical and commercial packaging, labeling and distribution.
The ideal candidate will have experience working with Contract Manufacturing Organizations (CMOs), good working knowledge of global GxPs supporting clinical and commercial packaging / labelling and distribution.
The candidate will work closely with the Technical Operations Supply Chain team to independently manage aspects of our global clinical and commercial pack / label contractors and distribution centers.
The candidate has a demonstrated ability to develop strategic plans 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 strategic planning / 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
- Help ensure quality of products produced / maintained at contractors through review and technical approval of batch production records, significant changes, related to the supply chain, and work with Technical Operations and CMOs to proposed solutions for recurring problems.
- Perform assessments for change controls within electronic document management systems
- Review and approve deviations and discrepancies at CMOs to assess product quality impact. Monitor effective checks of CAPAs.
- Subject Matter Expert for packaging / labeling of clinical and commercial products. Includes knowledge of manufacturing operations, label artwork / printing and label review.
- May function as Person-in-the-Plant (PIP) at CMO 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
Requirements :
- Provide strategic planning / 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
- Help ensure quality of products produced / maintained at contractors through review and technical approval of batch production records, significant changes, related to the supply chain, and work with Technical Operations and CMOs to proposed solutions for recurring problems.
- Perform assessments for change controls within electronic document management systems
- Review and approve deviations and discrepancies at CMOs to assess product quality impact. Monitor effective checks of CAPAs.
- Subject Matter Expert for packaging / labeling of clinical and commercial products. Includes knowledge of manufacturing operations, label artwork / printing and label review.
- May function as Person-in-the-Plant (PIP) at CMO 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 #LI-CS1 #LI-Hybrid
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