Head of Quality

Hobson Prior are currently recruiting for a Head of Quality to join a growing Oncology focused Biotech company in France on a permanent basis. 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).

Job Responsibilities:

• You will be accountable for the development, maintenance and improvement of the organisations Quality System in compliance with the regulatory requirements and the Company's strategy.
• Develops and maintains risk-based methodologies.
• Upholds up-to-date knowledge of FDA, EU, ICH & country specific regulations and other relevant guidance governing GxP activities across the organisation.
• 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.).
• Defines appropriate KPIs to monitor the efficiency of the Quality System and conducts quality reviews.
• 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.

Key Skills:

• Capability to work on an international environment.
• Pragmatism and flexibility without compromising quality.
• Ability to focus on practical, common sense and sensible approaches to find effective solutions with a focus on embedding strong quality and compliance behaviours.
• Excellent teamwork, interpersonal skills and negotiation skills, both internally and externally.

Requirements:

• Bachelor and/or Masters in a Science, Engineering or a related discipline is required, ideally in Quality or Pharmacy.
• Extensive GxP quality experience in clinics and post-marketing.
• A minimum of 7+ years' experience in Biotech/Pharmaceutical industry.
• 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 Competencies, Skills and Behaviours Technical Competencies
• Previous experience with computerized systems and GxP compliance requirements, involving both on-premises and hosted environments.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.