Start of mission
May 22, 2020
Job city
Marseille (13008)
Type of contract
CDI/ Permanent Contract

Description

Overall Objectives and Purpose of the role

Within the Compliance, IT & Portfolio Management Division, reporting to the VP, Compliance, IT & Portfolio Management, you will be responsible for developing and maintaining the Company's Quality System in alignment with the strategy and objectives and with the regulatory requirements (GxP).

The Quality System covers the whole value chain of the Company's portfolio, i.e. from Discovery to Post-Marketing programs / products, and all the related activities that are performed internally and externalized as well.

You will be someone who has the capacity to produce high quality results across multiple projects and prioritize demands while working under short deadlines associated with a fast-paced dynamic environment.

Profile

Main responsibilities and key tasks

Development, maintenance and improvement of Innate's Quality System in compliance with the regulatory requirements and the Company's strategy:

 
  • Oversees the management, issuance and tracking of the Company's Quality System and ensures it is appropriately documented and implemented (change controls, deviations, CAPAs, SOPs, validation protocols, product specifications, training documentation, etc.)
  • Develops and maintains risk-based methodologies
  • Defines appropriate KPIs to monitor the efficiency of the Quality System and conducts quality reviews
  • Maintains up-to-date knowledge of FDA, EU, ICH & country specific regulations and other relevant guidance governing GxP activities across the organisation
  • Oversees administration, tracking, and maintenance of the training program in accordance with the GxP requirements
  • Supports the management of the electronic document management system and all other electronic systems used as part of the Quality System
Audits & Inspections:
  • Establishes an appropriate audit program (internal, external)
  • Leads internal and external audits
  • Is the main Quality contact for external audits and inspections
Management of Quality department:
  • Manages the Quality department and develops it as part of the Company's transformation
  • Manages human resources in the department (recruitment, evaluation, training, development...)

Experience and Qualifications
  • Bachelor and/or Masters in a Science, Engineering or a related discipline is required, ideally in Quality or Pharmacy
  • 7+ years' experience in Biotech/Pharmaceutical industry
  • Extensive GxP quality experience in clinics and post-marketing  
  • Experience working with Contract Organizations, Service Providers, and other entities which provide GxP contracted services
  • Advanced knowledge and understanding of GxP regulatory requirements and implementation (FDA, EU, ICH & country specific regulations and other relevant guidance governing GxP activities)
  • Experienced understanding of drug-candidate development

Technical Competencies
  • GMP, GDP, GCP, GVP
  • ICH
  • Audits
  • Quality Reviews
  • Experience with computerized systems and GxP compliance requirements, involving both on-premises and hosted environments

Additional Skills/ Behaviours
  • Ability to work on an international environment
  • Ability to focus on practical, commonsense and sensible approaches to find effective solutions with a focus on embedding strong quality and compliance behaviors
  • Pragmatism and flexibility without compromising quality
  • Excellent teamwork, interpersonal skills and negotiation skills, both internally and externally
  • Able to interface well with all levels of personnel, including peers and other department heads such as: R&D, Pharmaceutical Operations / Supply Chain, Medical & Clinical Affairs, Safety, Regulatory, Supply Chain, Support activities, Project / Program Management...
  • Effective communication (verbal and written)
  • Strategic thinker, open-minded and flexible to adopting new ideas
  • Motivated, committed and self-managed
  • Ability to manage multiple projects in a dynamic environment and ability to meet fast-track timelines
  • Ability to be productive and successful in an intense work environment
  • Ability to adapt the work schedule to accommodate program priorities and other activities, including at an international level as needed
  • Ability to travel (domestic and international), sometimes on short notice
  • The applicant must be able to read, write and speak French and English