Seagen

Head EU Qualified Person

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 Associate Director, Head Qualified Person (QP, EU) is responsible for leading the Netherlands site QP organization to ensure compliance of local quality management systems with GxPs, Seagen procedures and national regulations in the EU. The Associate Director, Head Qualified Person is responsible for fulfilling Qualified Person responsibilities and for fulfilling the Responsible Person responsibilities related to GDP requirements.

Directing a team of EU QPs/RPs in Netherlands , the Associate Director, Head Qualified Person will ensure compliance with 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, EC/2001/20 and will ensure Annex 16 and 13 requirements are fulfilled.

The Head Qualified Person will also ensure compliance and implementation of the regulations stipulated within the scope of Good Distribution Practices (GDP) and is accountable for any quality post marketing requests or actions.

The position is a leadership role and is responsible for developing and leading a Quality Function at the site.

Principal Responsibilities

• Lead the NL site quality organization including management and mentorship of a team of QPs /RPs and quality.
• Provide quality leadership to site quality staff (QPs/RPs and quality staff) and coach them to deliver the local quality strategy so that Seagen Quality requirements are embedded in the site.
• Ensure that initial and continuous GMP/GDP training programs are implemented and
• Ensure a constant state of compliance and audit readiness is maintained in line with current regulations, Quality Standards and business.
• Ensure the QA function delivers efficient and effective business processes to support lean operation.

Implementation, maintenance and support of the Site Quality Management System

Implementation and maintenance of the Site 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

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 GMP/GDP regulations and ensure 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 and IMP) and Supply Chain Certification

• Responsible for the certification and release of commercial products for the European market to the applicable GMP/GDP directives, regulations, and guidelines.
• Responsible for the certification and release of investigational medicinal products (IMPs) for clinical studies in EU/country 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 Marketing Authorisation resp. the Product Specification File and the information submitted in Clinical Trial Authorisation (for IMPs) (if applicable).
• Ensures all batch documentation and transportation documents are available and compliant with local / region requirements to make a final disposition decision.
Fulfil the Qualified Person 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 and released to EU markets or to export from EU-market.
• Provide quality oversight for commercial and clinical activities in local affiliate.
• Execute responsibilities to certify the Supply Chain and issue QP-declarations for sites that are certified to meet GMP.

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 Complaint (product quality/product defect issues) investigations.

Product Recalls & Field actions Management

• Participate in risk assessment, decision-making, communication and risk reducing actions related to defective.
• Perform regulatory reporting and product withdrawal/recall for the EU.
• 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 pre-arranged program 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.
• Host Authority Inspections by local Health Authorities, provide inspection responses and ensure timely completion of related commitments and CAPA.
• 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.
• Act as the 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 DP requirements and Seagen Quality policies.

Required Qualifications

• Pharmacist or Master’s degree in scientific, quality-related field, biology, chemistry, or pharmaceutical studies, or equivalent combination of education, training and
• 7 years experience working in biopharmaceutical industry as Qualified Person status, and/or Quality Operational role at a site or country Experience as Responsible Person status is an advantage.
• 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
• GDP regulation 2013/C 343/01
• Fluent in English (written and spoken)
• In depth 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
• In depth knowledge of validation (assay validation, computer validation, process validation)
5 years of people management

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 Member state.

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 01/13/2023