Quality Systems Manager

GE HEALTHCARE AS; Oslo; On-site; NOK 1,000,000 - 1,250,000; Full time

Job summary

A leading global medical technology company in Oslo is seeking a Quality Systems Manager to oversee quality assurance processes, manage compliance with regulatory requirements, and ensure product safety. The ideal candidate holds a Master's degree in Life Science or Pharmacy and has significant experience in the pharmaceutical industry. Strong leadership and communication skills in both Norwegian and English are essential.

Qualifications

• Master's degree required, preferable in Life Science or Pharmacy.
• Proven experience in Quality Assurance within the pharmaceutical industry is necessary.
• Experience with regulatory inspections required.
• Strong oral and written communication skills in Norwegian and English.

Responsibilities

• Oversee processes associated with the deployment of quality policies and procedures.
• Manage overall quality risk to assure product quality and patient safety.
• Engage in internal and external inspections preparation.
• Drive site compliance with quality management systems and regulatory requirements.

Skills

Quality Assurance

Leadership

Regulatory compliance

Risk management

Problem solving

Communication (Norwegian)

Communication (English)

Education

Master's degree in Life Science or Pharmacy

Tools

Quality Management System tools

Job description

Overview

Join our team as 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
• Beta
• GMP (Good Manufacturing Practice)
• Kvalitetsstyringssystem
• Life Science
• Regulatory compliance
• Risikostyring

At GE HealthCare, we strive to create a healthier world by thinking big — unlocking opportunities for our teams, our customers and all the patients whose lives we touch.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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