Associate, Quality Assurance

vor 2 Wochen

Zug, Schweiz Seagen Vollzeit

Seagen is a global multi-product biotechnology company that develops and commercializes innovative therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to four marketed products, we are advancing a strong product pipeline of novel therapies for solid tumors and blood related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients.

Summary:
This position will support the Global data collection automatization activities to improve the CMO and suppliers data collection and KPI process establishment. The role reports into the Senior Director of External Quality. The role sits within a growing External Quality Operations team that is part of our expanding Global Center of Excellence focused on External Manufacturing and Testing.

**Responsibilities**:

- KPI program management for Global Quality Operations and reporting
- Responsible for Training coordination for Global External Quality teams
- Responsible for establishing and maintaining different IT tools for executing work to increase effectivity
- Responsible for establishing process for identifying and creating software solutions for data extraction from different IT systems
- Responsible for creating and maintaining the Power BI dashboard for External Quality KPIs
- Support new IT system implementation; may participate in testing functionality to support Quality operations processes
- Be a super user for some of the electronic systems e.g. Veeva, Oracle etc.
- Be ambassador of TOPS Operational Excellence representing External Quality department
- Support regulatory inspections as process owner of Seagen CMO KPI process
- Write and review Standard Operating Procedures as needed
- Owner of the Process Improvements projects follow up process in External Quality
- Support Implementation of risk management in External Quality
- Responsible for maintaining the quarterly KPI and risk register of CMOs
- Responsible for providing External quality input to TO’s monthly score card

Qualifications:

- 3+ years’ experience in the regulated pharmaceutical industry,
- Experience in Project management and managing global action plans
- Good communication skills and proven ability to work well with senior internal and external stakeholders
- Experience with electronic documentation management systems preferred.
- Expert in working with Excel, power point and other office software’s
- Ability to prioritize work and handle multiple assignments, while maintaining a high level of quality.
- Fluency in English speaking and writing is a must.

**Education**:

- Masters degree in a scientific discipline (Pharmacy, Chemistry, Biology, etc.) or similar.
- Training in computer science and/or automation is desirable

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