Senior Manager, Responsible Person

2 mesi fa

Lazio, Italia Confidenziale A tempo pieno

Description Position at Seagen 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 Position Summary:
The Quality Responsible Person (QRP) is responsible for fulfilling the Responsible Person and GDP responsibilities in the Italian market. The QRP may act as the GDP Responsible Person (RP) in accordance with European directives, European GMP, national competent authority requirements or national law. The QRP oversees and manages the local quality management systems and ensures the organizations meet their compliance obligations. The QRP 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 QRP 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 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 and required 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 Deviation, CAPA, Change Control Management and Complaint Management Ensures deviations are reported, investigated, managed and closed on time in the electronic QMS according to Seagen procedures Oversees the affiliate CAPA process and ensures CAPA are implemented, followed-up and closed on time in the electronic QMS 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 ChangeControl process and ensures change requests are implemented, followed-up and closed on time in electronic QMS 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 in front of AIFA (local health authority) or any local quality vendor or distributor/wholesaler Quality intelligence Ensures local regulatory information related to quality topics and assesses impact for Seagen activities GDP activities Ensure medicinal products are distributed under conditions that meet the GDP guidelines Ensuring that suppliers and customers are approved Approving 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 Qualifications:

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