Quality Assurance Responsible

Key accountabilities : The Quality Assurance Manager (Non Drug) ensures active Quality management of contract manufacturing organizations and related Non Drug products assigned to them. This will be in line with current GxPs, applicable regulations, and company requirements providing Quality leadership and oversight to the organization, interfaces and network. The QAM acts as Quality responsible person and the first escalation to resolve Quality issues within scope promptly and to minimize the risk to Sanofi. Duties

• Ensures that an appropriate Quality oversight of Contract Manufacturing Organizations (CMOs) and sub-contractors in the scope of responsibility, including appropriate Quality agreements and audits, is in place
• Guarantees compliance with GxP, applicable regulations and corporate requirements for all regulated activities
• Delivers against key Quality KPIs/metrics and drives results that ensure site compliance on a consistent and continuous basis
• Ensures identification, assessment, control and communication of risks involving components, raw materials, finished pharmaceuticals, within scope of responsibility
• Ensures the deviation and change control activities are consistently and timely managed
• Ensures implementation and evaluation of corrective and preventive actions to address systemic issues
• Support definition and implementation self-evaluation and continuous improvement tools
• Support set up and roll out Quality culture

The QAM will also support business units in the assigned region in the management of new business opportunities, product launches as well as in setting up Quality relevant contracts Background and experiences :

• Advanced Degree (Master) in a science/health field (e.g., Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalent
• At least 2 years of work experience in Quality Assurance, Quality Control and/or Production
• Should demonstrate flexibility, proactivity and be able to communicate efficiently with various stakeholders internally and externally
• Should demonstrate solid oral communication and writing skills in an international environment
• Fluent in English

Information :

• Company : Opella
• Position : Quality Assurance Responsible
• Location : Budapest
• Country : HU