Quality Lead: GMP, CAPA & Lean Excellence

MS0229 GE Healthcare AS; Oslo fylke; On-site; NOK 900,000 - 1,200,000; Full time

Job summary

GE HealthCare AS in Norway seeks a Quality Lead Specialist to ensure GMP compliance in sterile and aseptically manufactured products. You will lead quality systems (deviations, CAPA, risk management, document control, training) and support SAP processes and artwork approvals in collaboration with multiple functions.

You will drive change control, internal audits, and regulatory inspections, while applying LEAN principles to continuous improvement and data-driven quality management.

Qualifications

• Master’s degree in pharmacy, chemistry, biotechnology, engineering, or another relevant field.
• Relevant experience in quality assurance within the pharmaceutical industry with leadership experience.
• Experience in sterile or aseptic manufacturing and GMP regulations (EU GMP and Annex 1).
• Experience with deviation management, CAPA, change control, internal audits, risk management, and training systems.
• Experience with document control and GMP procedure development.
• Proficiency in analyzing and visualizing quality data using Excel (pivot tables, charts, dashboards).
• Fluent in Norwegian and English, written and spoken.

Responsibilities

• Take overarching responsibility for GMP compliance in sterile/aseptic manufacturing environments.
• Support QA of SAP-related processes and artwork approvals with cross-functional teams.
• Lead change control activities with risk-based assessments and quality approvals.
• Develop and manage quality systems (deviations, CAPA, risk management, document control, training).
• Provide QA support and guidance across production, labs and support functions.
• Lead LEAN-based improvement, solve problems, and analyze quality data for QMR.
• Draft, review and approve GMP procedures and related documents.
• Represent the area in audits and regulatory inspections and ensure follow-up of observations.
• Coach and train colleagues in GMP, data integrity and quality systems.

Skills

GMP regulations

CAPA

Deviation management

Risk management

Document control

LEAN principles

Quality data analysis

Excel dashboards

Regulatory inspections

Cross-functional collaboration

Education

Master’s degree in pharmacy, chemistry, biotechnology, engineering, or another relevant field

Job description

GE HealthCare AS in Norway seeks a Quality Lead Specialist to ensure GMP compliance in sterile and aseptically manufactured products. You will lead quality systems (deviations, CAPA, risk management, document control, training) and support SAP processes and artwork approvals in collaboration with multiple functions.

You will drive change control, internal audits, and regulatory inspections, while applying LEAN principles to continuous improvement and data-driven quality management.