Group Quality and Regulatory (QARA) Head Radiology & QARA Head Radiology Norway

Core functions Head of QARA Radiology Unilabs

The Head of QARA Radiology provides regulatory and quality oversight for the Business Unit and works with quality managers responsible for assigned countries and clusters. The Head of QARA Radiology is a resource for quality direction and strategy, regulatory interpretation, and problem resolution for the Business Unit.

• Participate to the development and deployment of a strong Quality Culture from the company’s executive management to the rest of the organization.
• Ensure Quality is visible and available to all levels of the Business Unit organization.
• Drive the standardization and harmonization of quality management system for the Radiology Business Unit in collaboration with Group QARA and other respective functions and experts.
• Coordinate the definition, monitoring, reporting and assessment of performance-related information for all sites across Radiology business unit.
• Lead projects that impact the Quality Management strategy or the organizational structure, being responsible for the implementation of the projects within the given framework (time, budget, quality) and manage the projects through Key Performance Indicators.
• Partner with senior leadership to review potential business opportunities and develop quality strategies.
• Provides interpretation of regulatory and accreditation requirements as well as guidance on meeting
• Produces quality results with a sense of urgency.
• Prepare, facilitate and follow-up quality meeting data/presentation.
• Ensure that quality related incidents are reported, documented, investigated and followed up in a systematic way across all geographies. Assists in root cause analysis and corrective action efforts, when needed.
• Highlight potential threats and opportunities for quality through systematic risk assessment.
• Facilitate the communication and sharing of best practices and good examples.
• Builds and develops a high performing team

Core functions Head of QARA Radiology Unilabs

• Ensures that the quality management system demonstrates regulatory compliance per ISO 9001, and other applicable regulations and standards from customers.
• Follows group policies and procedures.
• Promotes a culture of quality by educating others in quality management system fundamentals, programs and tools.
• Develop quality goals and objectives in collaboration with Group and local functional heads, assists in execution of these goals and report results and any need for improvement to hierarchical superiors.
• Prepare quality meeting data/presentation.
• Conducts Quality Management Review meeting at least once per year in cooperation with laboratory management and Country Leadership Team.
• Ensures non-conformances, adverse events and complaints are identified and documented and that timeliness requirements are met. Assess risk, assists in root cause analysis and corrective action efforts. Monitors trends and create reports for periodic quality meeting and management review.
• Plan and take part in internal audits. Follow-up of actions following audits.
• Participates in the preparation of certification dossiers, accompany auditors (e.g. ISO quality inspectors) during audits of the radiology institutes and coordinates responses to audit findings.
• Reviews / approves standard operating testing procedures and change controls before release.
• Ensures regulatory compliance of all radiology institutes by maintaining up-to-date knowledge of requirements and coordinating activities to fulfill requirements.
• Ensures appropriate implementation of the risk management procedure in all radiology institutes.
• Performs other duties as assigned.

Organization

• Reporting line: Head Quality and Regulatory Affairs
• Part of the Group Operations Organization
• Location: Oslo.
• Full time position
• Travelling within the región (~20%)

Personal and professional attributes

• Excellent leadership capability. Outgoing and dynamic.
• Performance driven. Customer conscious. Challenging.
• Ability to influence and guide others at all levels of management.
• Rigorous, organized, autonomous.
• Ability to work independently and initiate contacts as necessary
• Excellent problem solving, risk analysis and negotiation skills.
• Able to work effectively under pressure.

Education, Experience and Skills

• Master’s Degree in a technical/ process engineering/QA discipline, Advanced Degree preferred, with significant related professional experience within the healthcare environment.
• Fully versed in ISO 9001 and Risk Management.
• Demonstrated in-depth knowledge in quality process mapping and development.
• Demonstrated ability to affect change.
• English fluent as a must (presenting, writing, reading). Minimum Years Recommended and/or Preferred: 8-10 years.