Senior Operations Quality Assurance Manager
4 weeks ago
The Senior Operations Quality Assurance Manager - Labeling and Distribution is a critical role responsible for ensuring the quality of storage and distribution of clinical and commercial products, raw materials, and GMP intermediates. This individual will oversee the end-to-end quality process, identify and mitigate risks, and escalate issues as necessary.
Key Responsibilities- Maintain end-to-end quality standards for GxP warehousing and transportation management systems.
- Partner with the Exelixis 3PL network to ensure quality oversight, including release of goods for shipment, temperature monitoring, and audit support.
- Drive process improvements for returned goods and identify and mitigate risks associated with logistics and warehouse storage of supply chain.
- Define and oversee tracking and trending of 3PL quality metrics and supported systems.
- Interpret and apply applicable Health Authority regulations and guidance across the 3PL network and Exelixis' Quality System.
- Communicate temperature excursion reporting requirements to stakeholders and review/approve TE reports for accuracy/completeness.
- Execute clinical and commercial artwork and labeling, including vendor oversight and resolving quality issues.
- Deliver timely results on company core objectives, per supply plan, and drive for results.
- Partner with QA and cross-functional teams, including Production and Supply Chain, Clinical Development/Operations, and Regulatory Affairs.
- BS/BA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and a minimum of 9 years of related experience.
- MS/MA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and a minimum of 7 years of related experience.
- Equivalent combination of education/training and experience.
- Demonstrated knowledge of GxP, Health Authority Regulations, Quality Systems, and technical expertise in warehousing/storage and transportation/shipping processes and product quality decision-making.
- Knowledge of biologics and chemical products preferred.
- International/global experience preferred.
- Experience with participation in regulatory inspections and audits, presenting or defending departmental systems and decisions.
Exelixis offers a comprehensive benefits package, including a 401k plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program and long-term incentives.
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