Seattle Genetics

Qualified Person

Description

Seattle Genetics is an emerging global multi-product biotechnology company that develops and commercializes innovative antibody-based 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 two 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 Seattle Genetics can be found at www.seattlegenetics.com.

Position Summary

The Qualified Person (QP) is responsible for fulfilling QP responsibilities in relation to batch release of commercial (product for sale or supply in the EU or for export) and clinical product, in accordance with the requirements of EC/2001/83, EC2001/20 and Annex 16 and 13 requirements, as applicable.

The Qualified Person performs the QP responsibilities to ensure compliance with GxPs, Seattle Genetics procedures and national regulations.

The Qualified Person (QP) is responsible for ensuring that, prior to the certification of any given batch of drug product and finished goods, each batch has been manufactured and tested in accordance with the requirements of its Marketing Authorization or Product Specification file and the principles of current Good Manufacturing Practice (cGMP) prior to final release of the batch.

Principal Responsibilities

• Ensure that each GMP batch is produced and analysed in accordance with the cGMP guidelines and European directives 2001/83/EC, the Quality Assurance Agreements and the Marketing Authorisation.
• Ensure that each GMP batch for a clinical trial is produced and analysed in accordance with cGMP guidelines and European directives 2001/83/EC, regulation 536/2014 as amended, the Quality Assurance Agreements, the Product Specification File (PSF), and the information submitted in Clinical Trial Authorisation.
• Verify that each batch of medicinal product is distributed under conditions that meet the GDP guidelines.
• Release or reject of unlabelled Drug Product and Finished Drug Product.
• Maintain a register (or equivalent document) as a record of product batches certified by Qualified Person prior to release.
• Ensure the expiry date is aligns with the approved shelf life.
• Continuously improve and maintain the Quality System to remain in compliance with the applicable GMP/GCP regulations and local requirements.
• Provide support to improvements of the Quality System documentation system to ensure the system remains current.
• Participate in external audit program including follow-up activities (if applicable).
• Provide QP support and ensure the appropriate cGMP and/or study documents, deviations, OOS/OOT, change control, CAPA, etc. have been approved.
• Assist in regulatory or other inspections.
• Execute responsibilities to certify the Supply Chain.
• Issue QP Declarations for sites that are certified to meet GMP requirements.
• Participate in risk assessment, decision-making, communication and risk reducing action related to defective product.
• Perform regulatory reporting and product withdrawal/recall for the EU Market.

Qualifications:

• Qualification requirements as laid down in the Directive 2001/83/EC and the following directives:
• EU Directive 2003/94/EC (GMP for medicinal products for human use).
• The Rules Governing Medicinal Product in the European Community, Volume 4: Medicinal products for human and veterinary use: Good Manufacturing Practices.
• (Bio) Pharmaceutical background.
• Fluent in English and Dutch.
• Actual knowledge of GMP and other applicable regulatory requirements.
• In depth 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.
• In depth knowledge of validation (assay validation, computer validation, process validation).
• At least 1 year of relevant experience in a pharmaceutical setting, in case of having completed full university course of pharmacy (6yrs).
• For other completed university studies, at least 2 years of relevant experience in a pharmaceutical setting are applicable.

Education:

• Completion of a university course of study in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry, and technology, biology or a course recognized as equivalent by the Netherlands.

Seattle Genetics

Seattle Genetics is an Equal Opportunity Employer

Submitted: 02/07/2020