Senior Quality Risk Management Officer

Geleen, Netherlands

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Senior QA Officer for Quality Risk Management (QRM), sitting in the Audit and Inspection team, works with a team of auditing professionals to carry out variety of tasks related to the Quality Risk Management and Inspection Readiness.

You are responsible as the main contact to consult and discuss for any QRM activities on site. You provides systematic and operational expertise to the management of a comprehensive and integrated risk management program which meets Lonza internal standards for Cell and Gene Therapy manufacturing.

You are responsible for providing training and development of the site Quality Risk Register with the departmental managers. Key management deliverables are to provide general leadership, guidance and support team members to raise the aware of Quality Risks and the mitigations required.

As you sit in the Audit and Inspection team, you support the customer and regulatory inspections, as well as internal audits.

Key responsibilities:

Quality Risk Management:

  • Provide training and mentoring support to the team members with respect to the Quality Risk Management program. Involve in the development of training curriculum in support of develping a QRM culture.
  • Co-ordinate and facilitate on site Quality Risk Management Programs with departmental managers, with the aim to have a mature Quality Risk Management Program and a Quality Risk Register.
  • Support to integrate Quality Risk management into relevant elements of the Pharmaceutical Quality System.
  • Provide Technical Expertise to the Risk Assessment teams at the various Site levels.
  • Escalation and communication of risks via Hoshin Meetings to ensure visibility to Management.

Audit / Inspection / Observation CAPA management (when required by the Audit and Inspection Manager):

  • Plan and coordinate both external and internal audits. Support in maintaining an audit calendar that’s visible to relevant Department managers.
  • Support in perform and execute the internal audits according to the plan.
  • Serve as an internal auditor for the site. Support in preparation of Internal Audit Reports, Observations and CAPA follow-up.
  • Ensure all internal relevant parties are notified of any potential audits and coordinate to ensure all required personnel are available for the audit.
  • Maintain the audit records. Work with the Department Managers to assign observations to the relevant subject matter experts (SMEs).
  • Ensure audit / inspections Corrective and Preventive Actions (CAPAs) are completed to the agreed timeframe and effectiveness completed to prevent recurrence.
  • Involvement in the site for the appropriate support of the preparation, conduct and follow-up of external audits.
  • Support in fulfill the audit related Key Performance Indicators (KPIs) for the facility.
  • Ability to track key Quality metrics for in reporting into the Cell and Gene Business Unit
  • Ensure staff is meeting inspection readiness objectives and deliverables on time and in-full, perform key functions and support overflow of tasks needed to ensure deliverables are met.
  • The Inspection readiness Expert leads the process of weighing the risk of the events and search for effective, efficient, and compliant solutions.

Facility Support:

  • Develop and provide audit related training to the team members to ensure that there is enough auditing and audit handling skills within the team and the facility.
  • Develop and provide auditor training to the identified personnel to ensure that the facility has adequate internal auditors.

Key requirements:

  • Must have GMP, Quality, and Risk Management knowledge.
  • Strong knowledge of Quality Risk Management processes, flow, and requirements.
  • Excellent communications skills with both written and verbal. Experiences with regulatory and customer interaction for audit.
  • Compliance knowledge of regulations in multiple GMP area(s); ability to translate regulations into operational requirements (21 CFR 210, 211, 600s, 1271, as well as Eudralex Volume 4 Part 4 for ATMP Manufacture).
  • Technical writing and reviewing of observation reports and responses.
  • Attention to detail and ability to influence others in a team environment.
  • Action-oriented and customer-focused and skilled in decision-making, a team player in building relationships, problem solving, conflict management, planning and organizing, and analytical thinking.
  • Knowledge of Cell and Gene Therapy Products and Processes.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R19816