Head ESO QA Small Molecules

Head ESO QA Small Molecules

Sandoz

Kundl, Austria

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Lead the teams of ESO Quality Assurance Managers, the Sandoz New Product Supply & Launch (NPS&L) QA team, and the ESO EU Release hubs in various locations around the globe within ESO Sandoz Small Molecules (SM);
• Ensure the definition of clear targets and objectives for all team members;
• Quality business partner to Head ESO Small Molecules;
• Ensures Quality Oversight over Sandoz products manufactured at third parties, their compliance to the marketing authorization and cGxP requirements including the annual quality reviews summarized in APQR;
• Drive continuous improvements as applicable during manufacturing, QC testing and distribution throughout shelf life;
• Ensure Quality Assurance Agreements between Sandoz and 3rd party suppliers are in place and kept current. Ensure escalation and remediation in case of non-adherence;
• Monitor GxP compliance and inspection readiness status at the suppliers, initiate for-cause audits as required, review corrective and preventive action and ensure timely implementation;
• Ensure the integration of ESO requirements into the Sandoz Quality Management System and its continuous improvement;
• Ensure Quality issues and risks at the assigned third party suppliers are adequately and timely managed, escalated, resolved and follow up measures are defined and implemented. Ensure a system is in place, to effectively and efficiently manage and oversee the resolution of GxP issues, to review and approve critical deviation investigations, potential notifications to Health authorities and market interventions;
• Ensure senior management is notified of significant GxP events through the escalation process;
• Take a leadership role in the selection, maintenance and phase out of third party manufacturers;
• Ensure that quality and compliance related risks are an integral part of all kinds of business decisions;
• Initiate, manage, support and supervise selected Quality and Transformation projects and ensure that quality problems and technical matters are resolved consistent with global GxP standards;
• Ensure a performance management system is in place and adequate Key performance indicators are defined, to measure ESO QA performance, third party product quality performance and supplier performance related to Quality Compliance and established Quality business processes, setting continuous improvement targets supporting Sandoz will meet its company objectives;
• Collaborate within Global Quality and its different functions, ESO Operations, Procurement, Supply Chain, MS&T and commercial stakeholders being an ambassador for the product quality of Sandoz products sourced via third parties;
• Review KQIs of internal SRTs and KPI’s of external suppliers/contract manufacturers to monitor performance and initiate remediation projects in case required;
• Support direct reports in their leadership development and talent management to continuously strengthen the organization and ensure adequately staffed teams with qualified personnel;
• Management of all external QC activities with a specific focus on EU retesting labs in a cGMP compliant and cost-effective manner;
• Develop and execute a dedicated ESO quality plan to drive continuous improvement and corrective measures to enhance quality oversight;
• Ensure and provide guidance on Data Integrity and eCompliance.

What you’ll bring to the role:

Essential Requirements:

• University Degree in Natural Sciences (Chemistry, Pharmacy, Biology);
• At least 15 years’ experience in the pharmaceutical industry, e.g. in Production/Technical Operations and/or Quality Assurance;
• Thorough knowledge cGxP of major HA requirements (US FDA, PMDA, EMA, MHRA, ANVISA etc) and proven track record of remediation actions;
• Technical understanding of manufacturing process and /testing process with focus on oral solid dosage forms;
• Business acumen, experience in financial processes & operational excellence;
• Knowledge in Supplier Relationship Management;
• Logical/Strategic thinking and planning;
• Excellent interpersonal skills, including leadership, organizational, analytical, intercultural communication, and negotiation;
• Experience in an international matrix organization;
• Strong understanding of risk assessment and risk management fundamentals/tools;
• Languages: English proficiency, additional languages are an advantage.

Apply Now