Senior Manager Pharmaceutical Affairs, Deputy Responsible Pharmacist

Global Quality Paris, France


Description

Position Summary:

The Sr Mgr, Pharmaceutical Affairs will implement French Affiliate Exploitant quality management systems and make sure the organization meets its compliance obligations connected to an establishment license for its specific business model. The person will also support the Global QA Compliance team in carrying out compliance activities. This role also supports the global country quality organization with special focus on European country quality activities.  

  • Assist the Pharmaceutical Affairs Director for all regulatory and pharmaceutical activities in compliance with the provisions of the Public Health Code, French laws and group policies
  • Ensure the legal responsibilities of the Interim Responsible Pharmacist (Deputy) as defined by article R 5124.36 of the Public Health Code (CSP) replacing the Responsible Pharmacist
  • From an operational point of view, ensure the compliance of advertising and information activities

 
 Principal Responsibilities 

  • In compliance with the application of the rules of the public health code, good practices, the regulations in force inherent in the certification of promotional information, European regulations and by delegation of the responsible pharmacist
  • Participate in the application of the promotional information charter and its repository within the French Affiliate
  • Participate in coordinating activities linked to the product launches  
  • Ensure the information (promotional/advertising and non-promotional) review and validation process
  • Participate to implement all quality and pharmaceutical aspects of the local French affiliate/Exploitant organization & European country organizations
  • Help to continuously improve and maintain the Quality System to remain in compliance with the applicable GMP/GDP/GPVP regulations and local requirements for French affiliates/Exploitant 
  • Provide support to improvements of the Quality System documentation system to ensure the system remains current with focus on Corporate and French Affiliate procedures
  • Participate in internal and external audit programs including follow-up activities (if applicable)
  • Participate in and assist the Responsible Pharmacist on local regulatory or other inspections for French affiliates 
  • Participate in and assist the Responsible Pharmacist on managing local recalls and complaints
  • Participate in managing CAPA plan implementation both from relevant audits and Inspections
  • Assist Responsible Pharmacist to be the single point of contact for all quality related matters French affiliates/Exploitant
  • Participate in risk assessment, decision-making, communication, and risk reducing action related to defective product
  • Manage annual product quality review and/or oversee management review pan European and also local countries if and when needed
  • Support Audits when necessary
  • Manage the documentation GAP assessment process for French affiliates
  • Set personal performance goals and provide input to departmental objectives
  • Maintain and communicate work priorities to meet goals and timelines
  • Complete all job-related training while striving to continuously improve on knowledge and skills in quality, compliance, and technology

Qualifications :

  • Actual knowledge of GMP and 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
  • Experience in the certification of promotional information
  • Experience in Pharmacovigilance, promotional information /advertising and non-promotional information validation process, and regulatory affairs
  • Must be capable of assessing compliance to quality requirements using sound judgement and decision-making skills
  • Auditing experience
  • Experience in working with regulatory inspection 
  • Work experience in a country quality set up is preferable
  • At least 5-7 years of relevant experience in a pharmaceutical setting

Education:

  • Completion of a university course of study in Pharmacy

As a leading employer in our industry, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. To learn more about Seagen, please visit www.seagen.com 
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.