Seagen

Qualified Person EU

Technical Operations & Process Sciences - Amsterdam, Netherlands

Description

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. More information about Seagen can be found at www.Seagen.com

Position Summary

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 local Marketing Authorization or Product Specification File and the principles of current Good Manufacturing Practice (cGMP) prior to final release of the batch to the market. The QP is responsible for fulfilling the Responsible Person and GDP responsibilities in the respective markets. The QP may act as a Qualified Person (QP) or GDP Responsible Person (RP) in accordance with European directives, European GMP, national competent authority requirements or national law. The QP oversees and manages the local quality management systems and ensures the organizations meet their compliance obligations. The QP oversees the compliance and implementation of the regulations stipulated within the scope of Good Distribution Practices (GDP) or Good Manufacturing Practices (GMP) of drug products. The QP is accountable for any quality post marketing requests or actions.

Principal Responsibilities

Implementation, maintenance and support of the Quality Management System.

Implementation and maintenance of the Quality Management System in compliance with local regulations and Seagen standards, including but not limited to:

• Deviation Management
• Corrective Action Preventative Action (CAPA) Management
• Product Complaints Management
• Change Control Management
• Documentation Management
• Training Management
• Recall Management
• Self-Inspection Management
• Quality policy
• Quality Risk Management
• Vendor Qualification and Quality Agreement Management
• And recommendation for improvements to the quality system supporting Seagen business in the affiliates/countries

Implementation of the Quality Systems in daily operations

• Quality responsibility for all Seagen products licensed, marketed, or supplied within Territory of responsibility
• Compliance with local as well as international regulations and inspection readiness
• Obtain / oversee the legal documentation required, e.g., license, to operate in the Territory
• Maintains up-to-date Quality Agreements
• Develops, implements and maintains local Quality procedural documentation (in accordance with Global policies and procedures and the local document management system, if required)
• Monitors performance indicators related to quality compliance
• Resolves quality-related issues
• Archives and maintains all quality documents in line with Seagen procedures and local legal requirements

Batch release (commercial product)

• Responsible for the certification and release of commercial products for the European market
• Ensure that each GMP batch is produced, packaged, and analysed in accordance with the cGMP guidelines, the Quality Assurance Agreements between the company units and the local Marketing Authorisation
• Ensures all batch documentation and transportation documents are available and compliant with local / region requirements to make a final decision on whether or not to release
• Fulfil the duties as outlined in European GMP guidelines or local directives
• Keeping appropriate records of any delegated duties
• Maintain a register (or equivalent document) as a record of product batches certified by the QP
• Provide quality oversight

Batch release (clinical product)

• Responsible for the certification and release of investigational medicinal products (IMPs) for the European market and clinical studies in EU according to the applicable GMP directives, regulations, and guidelines
• Ensure that each GMP batch is produced, packaged, and analysed in accordance with the cGMP guidelines, the Quality Assurance Agreements between the company units and the local IMPD resp. the Product Specification File and the information submitted in Clinical Trial Authorisation
• Ensures all batch documentation and transportation documents are available and compliant with local / region requirements to make a final decision on whether or not to release
• Fulfil the duties as outlined in European GMP guidelines or local directives
• Keeping appropriate records of any delegated duties
• Maintain a register (or equivalent document) as a record of product batches certified by the Qualified Person
• Provide quality oversight for clinical activities

Deviation, CAPA, Change Control Management and Complaint Management

• Ensures deviations are reported, investigated, managed and closed on time according to Seagen procedures
• Oversees the affiliate CAPA process and ensures CAPA are implemented, followed-up and closed on time according to Seagen procedures
• Ensures that an effective local / region change control process is implemented and compliantly managed within the affiliate / region
• Oversees the affiliate / region Change Control process and ensures change requests are implemented, followed-up and closed on time in Seagen systems according to Seagen procedures
• Support Product Complaints (product quality/product defect issues) in the investigation

Product Recalls & Field actions Management

• Acts as Affiliate Recall Coordinator and promptly performs any recall operations for all Seagen distributed products according to Seagen procedures
• Coordinates with local competent authorities in the event of recalls
• Provides assistance as required in the event of a field action, as determined by the Escalation team

Self-Inspection and Quality Audit Management

• Ensures that self-inspections of the affiliate / regional operations and quality system are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place
• Supports and participates in corporate organization audits and assists in audit preparation activities, including the development of CAPA plans and the close out of any audit action items

Contact with Local Regulatory Agency

• Acts as primary contact point for local regulatory agency
• Act as primary contact point to report or liaise with local distributors if any quality related supply chain issues with batches delivered to the Affiliate / region as not meeting the requested quality criteria

Quality intelligence

• Provide local regulatory information related to quality topics and assess impact for Seagen activities

GDP activities

• Ensure medicinal products are distributed under conditions that meet the GDP guidelines
• Ensure that suppliers and customers are approved
• Approve any subcontracted activities which may impact on GDP
• Single point of contact for all quality related matters for local affiliate and associated distributors
• Fulfil the duties as outlined in the GDP guideline
• Provide quality oversight of all local distribution and warehousing activities and ensure compliance to GMP/GDP requirements and Seagen Quality policies

Required Qualifications and Education:

• Completion of a university course of study in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry, and technology, biology or similar course recognized equivalent by the Member State or national competent authorities
• Verbal and writing proficiency in English
• At least 2 years of relevant experience within the pharmaceutical industry
• Auditing experience
• Experience in regulatory inspections
• Prior experience as a Qualified Person/ Responsible Person or in Quality functions in a GMP environment with experience with biologic products and small molecules in both clinical and commercial settings
• Actual knowledge of GMP, GDP 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

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 02/10/2023