GE HealthCare in Oslo is looking for a new Quality Systems Manager

The Quality Assurance manager - QA systems is responsible for managing the processes associated with Quality Assurance systems, to assure product safety and quality by driving business alignment to cGMP, regulatory & product license requirements and business objectives by managing quality systems, controls and continuous improvements.

Quality Assurance manager - QA systems will engage with the relevant support departments and build strong relationships with same.

You will demonstrate Role Model Leadership by facilitating, coaching, mentoring and developing your team.

Key responsibilities

• Owning the processes associated with the deployment of global policies and site quality procedures. Ensuring quality and site procedures are up to date and reflective of regulatory & industry and GE Healthcare internal standards requirements.

• Responsible for the overall quality risk management at site to assure product quality, patient safety & efficacy.

• Management of the processes of internal and external inspections, including Inspection readiness preparation, inspection execution and ensuring non-conformances are actioned & progressed to closure in a timely manner.

• Responsible for engaging strong intradepartmental and cross-functional / organizational relationships to drive quality system requirements.

• Driving site Regulatory Intelligence processes to ensure timely compliance with Regulatory requirements.

• Influencing site compliance to Quality policy, Quality Management System procedures, regulatory requirements, Product License Requirements and cGMP.

• Responsible for Quarterly Management Review process, analyzing the trend reports, identifying actions / gaps & driving continuous improvements.

• Driving EHS performance in the department in accordance with the requirements of the company’s 5S, safety and environmental management programs.

• Driving GMP training on site.

• Managing and/or support quality programs for Computer Software Validation, Data Integrity and Lifecycle for Analytical Method validation

Reporting lines:

Quality Assurance manager - QA systems report to the Director of Quality Operations

Required Qualifications

• Master’s degree , preferable within Life Science or Pharmacy.

• Proven track of Quality experience in the pharmaceutical industry

• Proven track of supervisory/management experience

• Experience with regulatory inspections

• Demonstrated experience with regulations in the pharmaceutical industries and knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes

• Strong oral and written communication skills in both Norwegian and English.

• The role requires physical attendance at the Oslo site

Required Characteristics

• Strong interpersonal and leadership skills

• Results orientated with a strong ability to effectively troubleshoot, and problem solve issues

• Exceptional planning skills to consistently deliver stretch targets and objectives