Senior QA Associate
Seagen is an emerging 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 three 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. More information about Seagen can be found www.seagen.com
The Senior Associate QA supports the Country Affiliates and Global Product Disposition quality management system in the Netherlands and across Europe. The role makes sure the organization meets its compliance obligations connected to an establishment license for its specific business model and supports Global QA Compliance team in carrying out compliance activities including Audits in Europe.
- Support and maintain all quality and pharmaceutical aspects of the local Country affiliate organization
- Continuously improve and maintain the Quality System to remain in compliance with the applicable GMP/GDP regulations and local requirements for country affiliates
- Provide support to improvements of the Quality System documentation system to ensure the system remains current with focus on Corporate Country Affiliate procedures
- Participate in internal and external audit programs including follow-up activities (if applicable).
- Support local regulatory or other inspections for country affiliates
- Actively manage CAPA plan implementation both from relevant audits and Inspections
- Review annual product quality review
- Manage the documentation GAP assessment process for Country affiliates
- QA review and release commercial and clinical products
- Ensure overall compliance of Clinical and Commercial products for all regions
- Ensure post-release surveillance commitments are met, including participation in product complaint investigations, Biological Product Deviation Reporting, Field Alerts, and Recalls
- Support product launch activities for introduction of product into new countries
- Complete all job-related training while striving to continuously improve on knowledge and skills in quality, compliance, and technology
- Actual knowledge of GMP and GDP and other applicable regulatory requirements.
- Knowledge and experience with quality systems, corrective action and preventative action system, statistical process control, risk management, FMEA and other key tools for managing quality performance.
- Knowledge of validation (analytical validation, computer validation, process validation).
- Must be capable of assessing compliance to quality requirements using sound judgement and decision-making skills
- Auditing experience
- Experience in working with regulatory inspection first hand will be preferable
- Work experience in a country quality set up is preferable
- At least 2-5 years of relevant experience in a pharmaceutical setting.
- Completion of a university course of study in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry, and technology, biology
- Ensures accountability
- Communicates effectively
- Manages conflict
- Optimizes work processes