TRD Pilot Plant Quality Control Head

Productivity:

• Full end-to-end responsibility, ownership, and accountability for the entire process from sample receipt to result release, including equipment ownership.
• Formulate strategies and make decisions to ensure the efficient and compliant operation of the Ivrea Site.
• Establish long-term strategy and resource requirements, periodically reviewing progress towards goals.
• Write and/or approve laboratory-relevant SOPs and review guidelines, Quality Modules, and all analytical work-related documentation.
• Ensure that all components, in-process materials, and test results are released in accordance with local/international regulations.
• Formulate KPIs to support strategic and quality objectives.
• Ensure lab processes follow compliant processes, including a high degree of Data Integrity assurance.
• Ensure method validations and other GMP analytical activities in support of IND/IMPD are planned and executed according to protocols and under the guidance of RLT development team.

Cost:

• Partner with the Director Pilot Plant RLT to establish operating and capital budgets; manage operating expense budget in the laboratory area.

Quality:

• Ensure all activities are performed according to the local Quality system and SOPs.
• Ensure that OOE, OOT, and OOS are properly and timely escalated to QA.
• Own investigation of all QC-relevant deviations and collaborate closely for all OOE/OOT/OOS investigations, ensuring they are conducted in a scientifically sound and timely manner according to SOPs.
• Define and implement appropriate corrective/preventative actions in due time.
• Support internal audits and external inspections according to the Novartis Corporate Quality Manual.

People/Culture:

• Act as a role model in accordance with the Novartis Values and Behaviors.
• Provide leadership, direction, and support to team members, ensuring they are adequately qualified and trained to achieve a high level of competence and are motivated to excel.
• Transfer knowledge and expertise to further empower lab team members.
• Drive for the internalization of a lean and quality-beyond-compliance culture.
• Create a positive working environment by providing honest and immediate feedback and coaching to resolve conflicts.
• Participate in the recruitment process to contribute to hiring the right people.
• Actively work at retaining and developing talents, identifying and responding to their technical and interpersonal development needs.
• Ensure the performance review process for all team members is executed.
• Effectively deal with poor performers in the laboratory.

HSE:

• Ensure changes and significant process steps within the area of responsibility are risk assessed according to standards and periodically reviewed.
• Ensure high level of attention for handling radioactive materials within the area of responsibility, running operations in full compliance with HSE guidelines (internal/external).
• Serve as a role model for HSE at the entire site by addressing HSE topics ad-hoc in the entire Site, including areas of indirect responsibility.
• Provide support to inspections carried out by Safety in the laboratory.

Key Performance Indicators 

• No critical audit findings and audit actions completed on-time to root cause level, both in own area and across processes.
• Timely close out of corrective actions implemented for deviations.
• Demonstrated positive trends in key quality management process measures (Overdue deviations, Overdues, CAPA effectiveness, etc.).
• Testing and technical release of results according to agreed delivery times.
• Active contribution to compliance activities.
• Cost and budget adherence.
• GMP and technical training conducted, registered, and followed up.
• Achieve KPIs with regard to quality, cost, people, and productivity (lead time adherence).
• Retention, absenteeism, compliance with succession plans.

Job Dimensions

Number of associates:                 10

Financial responsibility:               Manage operating expense budget in the laboratory area

(Budget, Cost, Sales, etc.,)

Impact on the organisation:                     High.

Ideal Background

Education (minimum/desirable):            University degree in natural sciences / Chemistry/ Biologic

Languages:                                         Fluent written and spoken Italian and English

Experience:               At least 5 years of Quality Control/AS&T experience within the pharmaceutical industry. Sound knowledge in GMP and related activities, analytical technology and equipment, incl. qualification and calibration.

Good know-how in common computer applications, e.g. MS Office, as well as in laboratory specific applications, e.g. LIMS, Chromeleon, 1QEM.