Job Description

ultrainnovative – Tackle rare and dynamic challenges

The Senior Manager, CMC QA will report to the Sr Director, CMC Quality Assurance This role supports UGX QA Lot Disposition team performing tasks related to disposition and documentation activities for UGX and UGT product lots. This position is responsible for oversight and management of the Lot Release system, working proactively and cross-functionally to ensure lots are released according to schedule and Patient need.

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:

1. Work proactively with TechOps planning function, to ensure lot release dispositions are clearly and appropriately scheduled.
2. Work proactively to schedule and facilitate Production Planning meetings to ensure complete planning for production and subsequent lot release.
3. Ensure review CMO executed manufacturing batch records per QA SOPs, according to schedule and internal KPI requirements
4. Ensure Certificate of Analysis documents are evaluated and found to be accurate by QC group.
5. Understand QA systems such as raw material disposition, deviations, and change control to ensure batch records are compliant with these systems.
6. Ensure batch record history files are compiled and KPIs are updated and current.
7. Apply disposition to lots of material manufactured for Clinical, Early Access, and Commercial use. This includes, but not limited to, Starting Materials, DS, DP, FG.
8. Ensures archival of completed and reviewed manufacturing batch records
9. Drive change control accuracy, completeness, and transparency through the Change Review Forum
10. Perform the Change Control QA Role, where needed
11. Identify opportunities for improvement in Lot Release and Change Control, and use continuous improvement tools to drive implementation of improvements
12. Perform QMS data collection and trending for all APQR activities
13. Plan and coordinate cross-functional meetings with QP/QO/RP.
14. Other duties as assigned.
15. For DS/DP, ability to be authorized to assign lot disposition (releases lots)

Requirements:

1. Bachelor’s degree in a science or related technical field with no less than 7 years relevant industry experience
2. Working knowledge of desktop computers
3. Demonstrated ability for detail-oriented work
4. This individual must exhibit strong compliance, organization, and communication skills.
5. In depth knowledge of pharmaceutical regulations including 21 CFR Part 11, GMPs, GCPs, GAMP 5, and Annex 11.
6. Extensive experience in managing multiple validation projects, developing plans, managing to project schedules and directing vendor/contract resources in creating CSV deliverables.
7. Diverse experience validating GxP-regulated applications for quality management, regulatory submissions, controlled document management solutions and clinical development
8. Must possess excellent communication, conflict resolutions, influence and problem-solving skills.
9. Deep understanding of the validation methodologies applied to on-prem applications and hosted environment.
10. Strong attention to detail, quality oriented
11. Must be self-motivated and comfortable in a fast-paced, demanding and dynamic work environment.

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