Seagen

Specialist, Quality Assurance Supply Chain Quality

Technical Operations & Process Sciences - Zug, Switzerland

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 Quality Assurance Specialist Supply Chain Quality is responsible for providing quality oversight of shipping and materials management operations. The Quality Assurance Specialist partners with Global Logistics, QC, External Quality, and Product Supply for transportation of clinical and commercial products across manufacturing stages, up to the final distribution service providers. In addition, the Quality Assurance Specialist provides quality oversight of clinical distribution shipping deviations, including temperature excursions. This Quality Assurance Specialist participates in improvement projects for supply chain quality processes and partners with cross functional teams to develop programs and strategies to ensure a safe and high-quality supply chain.

Principal Responsibilities:

• Perform quality review and approval of routine shipping requests.
• Review and approve temperature excursions and deviations that occur during shipment.
• Represent Seagen Supply Chain Quality in meetings with Logistics and Storage Site Vendor Quality.
• Represent Supply Chain Quality on cross-functional or external teams.
• Approve transportation lanes
• Perform Quality review of shipping qualification.
• Support logistic supplier qualification documents.
• Support customers and answer complex questions supporting a range of projects.
• Assess and approve change requests, deviations and CAPA.
• Create, Review and Approve SOPs
• Represent Supply Chain Quality on cross-functional or external teams
• Develop new business processes as part of a team.
• Process complex records that may involve external parties.
• Assess business processes for team and identify opportunities for continuous improvement to drive efficiency, scalability, and risk reduction.
• Influence cross-functional teams to meet compliance and business needs.
• Acts independently to determine methods and procedures on new assignments.
• Participate in Regulatory inspections.

Qualifications:

• Minimum 5 years of experience in the pharmaceutical industry
• Knowledge of GMP, GDP and other applicable regulations applicable to US and international regulatory agencies
• Minimum 2 years of experience with deviation, investigation and CAPA management
• In depth knowledge and experience with quality systems, corrective action and preventative action system, risk management, FMEA and other key tools for managing quality performance
• Experience with temperature-controlled logistics
• Knowledge of validation (shipping, equipment, facilities)
• Experience in regulatory inspections
• Thorough understanding of local compliance, as well as a sound ethical approach to business

Preferred Qualifications:

• Experience with quality management systems (QMS), electronic documentation management systems (EDMS) and ERP systems
• Must be capable of assessing compliance to quality requirements using sound judgement and decision-making skills
• Excellent verbal and technical written communication skills, interpersonal skills, and negotiation skills are essential
• Innovative, proactive, and resourceful; committed to Quality and continuous improvement

Education:

• BS/BA in relevant field

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 09/01/2023