דרושים Avs Supply Chain Project Manager ב-Ge Healthcare ב-Norway

Project Planning & execution:

• Develop and manage comprehensive project plans for supplier transfers including timelines, budgets, and resource allocations.

• Define project scope, objectives, and deliverables in alignment with business goal.

• Coordinate cross-functional teams including sourcing, engineering, quality, operations, and QARA.

• Monitor and track project progress, identifying and mitigating risks and issues throughout the lifecycle of the program.

• Lead regular project meetings, reporting status and providing regular updates to stakeholders and leadership teams.

• Ensure compliance to GEHC QMS and industry standards.

• Work closely with suppliers to ensure smooth transition, including knowledge transfer, validation and capability/ readiness assessments.

Risk Management & Compliance:

• Identify risks associated with supplier transfers and develop mitigation strategies with the program team.

• Ensure adherence to regulatory requirements including GEHC QMS standards and international medical device regulations and quality standards (ISO 13485, FDA 21 CFR Part 820, EU MDR, China NMPA, Japan PMDA) and other industry best practices.

• Conduct risk assessments (DFMEA, PFMEA) and implement contingency plans to prevent disruptions/ impacts to the program’s deliverables.

• Work with regulatory and quality teams to maintain documentation and approvals required for compliance.

Cost and Performance Management:

• Manage project budgets, ensuring cost efficiency while meeting performance goals.

• Optimize supply chain strategies to reduce costs, improve efficiency and maintain product quality.

• Track supplier performance post-transfer/implementation, identifying corrective actions if necessary to ensure long-term supplier sustainability.

Required Qualifications:

• Bachelor’s degree in Engineering, Supply Chain, Business Management or related field.

• Proven track of project management experience in supplier transfer, supply chain or manufacturing, preferably in the medical device industry.

• Experience managing global program teams and working across different time zones, cultures and regulatory landscapes.

• Experience in regulated industries such as medical devices, pharmaceuticals, aerospace, automotive.

• Strong knowledge of medical device manufacturing processes, validation and quality systems.

• Strong project management skills with experience in tools like MS Project and/or Smartsheet.

• Knowledge of supplier qualifications, validations and risk management.

• Strong problem-solving, negotiation and communication skills with the ability to work effectively across different cultures and time zones.

• Ability to manage multiple programs in parallel.

• PMP, Six Sigma, and/or Lean Manufacturing certification is a plus

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.

Description

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

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.

Project Planning & execution:

• Develop and manage comprehensive project plans for supplier transfers including timelines, budgets, and resource allocations.

• Define project scope, objectives, and deliverables in alignment with business goal.

• Coordinate cross-functional teams including sourcing, engineering, quality, operations, and QARA.

• Monitor and track project progress, identifying and mitigating risks and issues throughout the lifecycle of the program.

• Lead regular project meetings, reporting status and providing regular updates to stakeholders and leadership teams.

• Ensure compliance to GEHC QMS and industry standards.

• Work closely with suppliers to ensure smooth transition, including knowledge transfer, validation and capability/ readiness assessments.

Risk Management & Compliance:

• Identify risks associated with supplier transfers and develop mitigation strategies with the program team.

• Ensure adherence to regulatory requirements including GEHC QMS standards and international medical device regulations and quality standards (ISO 13485, FDA 21 CFR Part 820, EU MDR, China NMPA, Japan PMDA) and other industry best practices.

• Conduct risk assessments (DFMEA, PFMEA) and implement contingency plans to prevent disruptions/ impacts to the program’s deliverables.

• Work with regulatory and quality teams to maintain documentation and approvals required for compliance.

Cost and Performance Management:

• Manage project budgets, ensuring cost efficiency while meeting performance goals.

• Optimize supply chain strategies to reduce costs, improve efficiency and maintain product quality.

• Track supplier performance post-transfer/implementation, identifying corrective actions if necessary to ensure long-term supplier sustainability.

Required Qualifications:

• Bachelor’s degree in Engineering, Supply Chain, Business Management or related field.

• 8+ years of project management experience in supplier transfer, supply chain or manufacturing, preferably in the medical device industry.

• Experience managing global program teams and working across different time zones, cultures and regulatory landscapes.

• Experience in regulated industries such as medical devices, pharmaceuticals, aerospace, automotive.

• Strong knowledge of medical device manufacturing processes, validation and quality systems.

• Strong project management skills with experience in tools like MS Project and/or Smartsheet.

• Knowledge of supplier qualifications, validations and risk management.

• Strong problem-solving, negotiation and communication skills with the ability to work effectively across different cultures and time zones.

• Ability to manage multiple programs in parallel.

• PMP, Six Sigma, and/or Lean Manufacturing certification is a plus

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.