Seagen

Responsible Person, Germany

Technical Operations & Process Sciences - Munich, Germany

Description

Position Summary

The RP DACH is responsible for three countries, Germany, Austria and Switzerland, and acts as GDP Responsible Person Grosshandelsbeauftragter/ Fachkundige Person (Germany and Austria) / Fachtechnisch Verantwortliche Person (Switzerland) taking The RP Germany is responsible for the Affiliate Seagen Germany GmbH in Munich, Germany and the territories Germany and Austria, and acts as GDP Responsible Person Grosshandelsbeauftragter/ Fachkundige Person for Germany. The person is taking accountabilities according to AMBV, Arzneimittel-Bewilligungsverordnung and “Verantwortliche Person nach §52 AMG”. The incumbent is responsible for fulfilling German/EU-GDP responsibilities in the respective markets.

The RP Germany manages the local quality management systems and ensures the organizations meet their compliance obligations connected to an establishment license for its specific business model in the three countries. The RP oversees the compliance towards, and implementation of the regulations stipulated within the scope of Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP) of drug products, as far as applicable to the substance classes and business model of SeaGen in the DACH region. The incumbent is accountable for any Quality post marketing requests or actions.

Principal Responsibilities:

• Oversees all quality and pharmaceutical aspects of the local organizations independently from the management team and have full authority to give directives to all staff within the remit of quality and pharmaceutical operations.
• Verify that each batch of medicinal product is distributed under conditions that meet current GDP guidelines.
• Train and supervise any deputy RPs as applicable in the country legislations.
• Continuously improve and maintain the Quality System to remain in compliance with the applicable GMP/GDP regulations and local requirements.
• Fulfil the duties for the German entity as outlined in AM-HandelsV, especially §§ 1a, 6, 7, 7a.
• Provide support to improvements of the Quality System documentation to ensure the system remains current.
• Participate in internal and external audit and vendor qualification programs including follow-up activities (if applicable).
• Ensure the appropriate cGMP and/or study documents, deviations, OOS/OOT, complaints, recalls, returns, change control, CAPA, etc. have been approved, especially when assuming further senior oversight roles in Global Quality.
• Assist in, oversee, or lead regulatory or other inspections.
• Participate in or drive risk assessment, decision-making, communication, and risk reducing action related to defective product.
• Make sure the obligations of a RP under EU GDP guideline 2013/C 343/01 are adhered.
• Contribute and approve (annual) product quality review and/or oversee management review.

Qualifications:

• Degree in life science e.g. in pharmacy, chemistry, biology, biochemistry or any related technical discipline.
• Prior experience as a Quality Responsible Person or in Quality functions in a GMP environment with experience with biologic products and small molecules in both clinical and commercial settings.
• Language requirements: German and English (written and spoken).
• Actual knowledge of GMP, GDP and German regulations (e.g. AMG).
• 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.
• At least 8 years’ experience in a similar role in the pharmaceutical industry.
• 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 BfArM.
• Thorough understanding of local compliance, as well as a sound ethical approach to business
• Meddicine, veterinary medicine, chemistry, pharmaceutical chemistry, and technology, biology or a course recognized as equivalent by Swissmedic, BfArM or BASG; pharmacist preferred.

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 07/29/2022