Quality Lead Specialist

MS0229 GE Healthcare AS; Oslo fylke; Presencial; NOK 900.000 - 1.200.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

GMP regulations

CAPA

Deviation management

Risk management

Document control

LEAN principles

Quality data analysis

Excel dashboards

Regulatory inspections

Cross-functional collaboration

Educación

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

Descripción del empleo

Job Description Summary

Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market

Job Description

We are looking for an engaged and quality-focused Quality Lead Specialist to join GE HealthCare AS. This role carries an extended level of responsibility and will play a key part in ensuring quality and regulatory compliance within sterile and aseptic pharmaceutical manufacturing. You will have particular subject matter responsibility for the further development and operation of quality systems, such as deviations, CAPA, risk management, document control, or training systems, depending on qualifications. You will also contribute to change control, internal audits, and regulatory inspections. In addition, you will support the quality assurance of SAP-related processes and artwork and drive continuous improvement through a LEAN-based approach. This position offers a unique opportunity to make a meaningful impact on quality, efficiency, and patient safety in an international and highly regulated environment.

Key Responsibilities

Take overall responsibility for systems ensuring compliance with GMP requirements and quality standards within sterile and aseptic pharmaceutical manufacturing. Support the quality assurance of SAP-related processes and the approval of artwork and packaging materials in collaboration with relevant functions and the wider team. Contribute to change control activities through risk-based assessments and quality approval of changes, ensuring appropriate follow-up through to closure. Further develop and manage quality systems, including deviation management, CAPA, risk management, document control, and training systems, ensuring they are effective, risk-based, and compliant with regulatory requirements. Provide quality assurance support and subject matter guidance to manufacturing areas, laboratories, and support functions. Initiate and lead improvement activities using LEAN principles and structured problem-solving methodologies. Analyse quality data and trends and follow up on these for the Quality Management Review (QMR) process to identify improvement opportunities and strengthen the quality system. Take responsibility for drafting, reviewing, and approving procedures, work instructions, and other GMP documentation within your area of expertise. Represent your area of expertise during internal and external audits and regulatory inspections, ensuring effective follow-up of observations and findings. Contribute to the training, coaching, and competency development of colleagues in GMP, aseptic behaviour, data integrity, and quality systems. Take a subject matter leadership role in the management of deviations, quality investigations, and CAPA, ensuring quality, traceability, and timely follow-up. Act as a subject matter partner to management and QA colleagues, helping to prioritise and coordinate quality activities across departments.

Qualifications

Master’s degree in pharmacy, chemistry, biotechnology, engineering, or another relevant field. Relevant experience in quality assurance within the pharmaceutical industry, with a demonstrated ability to provide subject matter leadership and take ownership. Experience in the pharmaceutical industry, preferably within sterile or aseptic manufacturing. Strong knowledge of GMP regulations, including EU GMP and Annex 1. Experience with quality systems such as deviation management, CAPA, change control, internal audits, risk management, and training systems. Experience with document control and the development of GMP procedures. Experience analysing and visualising quality data using Excel, including pivot tables, charts, and dashboards. Strong analytical skills and a structured approach to problem-solving. Strong collaboration skills and the ability to communicate effectively across different functions and areas of expertise. Fluency in Norwegian and English, both written and spoken.

Preferred Experience

It would be an advantage if you have experience with: Quality-related processes in SAP and the approval of artwork, labels, or packaging materials. LEAN, Operational Excellence, or continuous improvement initiatives. Risk management and audits within regulated environments. Structured problem-solving methodologies.

Vi søker en engasjert og kvalitetsbevisst Quality Lead Specialist til GE HealthCare AS.

Rollen har et utvidet ansvar og vil være sentral i å sikre kvalitet og regulatorisk etterlevelse innen steril og aseptisk legemiddelproduksjon. Du vil ha et særlig faglig ansvar for å videreutvikle og drifte kvalitetssystemene, herunder avvik, CAPA, risikostyring, dokumentstyring og opplæringssystemet, og bidra i endringskontroll, internrevisjon og myndighetsinspeksjoner. Du vil også bidra til kvalitetssikring av SAP-relaterte prosesser og artwork, og drive kontinuerlig forbedring gjennom en LEAN-basert tilnærming. Stillingen gir en unik mulighet til å påvirke kvalitet, effektivitet og pasientsikkerhet i et internasjonalt og høyt regulert miljø.

Arbeidsoppgaver

Ha et overordnet faglig ansvar for å sikre etterlevelse av GMP-krav og kvalitetsstandarder innen steril og aseptisk legemiddelproduksjon. Bidra til kvalitetssikring av SAP-relaterte prosesser og godkjenning av artwork og emballasjemateriell i samarbeid med øvrige fagmiljøer og teamet. Bidra i endringskontroll med risikobasert vurdering og kvalitetsgodkjenning av endringer, og sikre oppfølging frem til lukking. Videreutvikle og drifte øvrige kvalitetssystemer, herunder avvik, CAPA, risikostyring og dokumentstyring og opplæringssystemet, og sikre at de er effektive, risikobaserte og i samsvar med regulatoriske krav. Gi kvalitetssikringsstøtte og faglig veiledning til produksjonsområder, laboratorier og støttefunksjoner. Initiere og lede forbedringsarbeid gjennom LEAN-prinsipper og strukturerte problemløsningsmetoder. Analysere kvalitetsdata og trender, og følge opp disse for kvalitetsledelsens gjennomgang (QMR) for å identifisere forbedringsmuligheter og styrke kvalitetssystemet. Ha ansvar for å utarbeide, revidere og godkjenne prosedyrer, arbeidsinstrukser og annen GMP-dokumentasjon innen eget fagområde. Representere fagområdet i interne og eksterne revisjoner samt myndighetsinspeksjoner, og sikre effektiv oppfølging av observasjoner. Bidra til opplæring, veiledning og kompetanseutvikling av kolleger innen GMP, aseptisk adferd, dataintegritet og kvalitetssystemer. Ta en faglig rolle i håndtering av avvik, kvalitetsundersøkelser og CAPA, og sikre kvalitet, sporbarhet og fremdrift i oppfølgingen. Fungere som faglig sparringspartner for ledelsen og kollegaer i QA, og bidra til å prioritere og koordinere kvalitetsaktiviteter på tvers av avdelinger.

Kvalifikasjoner

Mastergrad innen farmasi, kjemi, bioteknologi, ingeniørfag eller tilsvarende relevant utdanning. Relevant erfaring fra kvalitetssikring i farmasøytisk industri, med dokumentert evne til å ta faglig lederskap og eierskap. Erfaring fra farmasøytisk industri, fortrinnsvis innen steril eller aseptisk produksjon. God kunnskap om GMP-regelverk, inkludert EU GMP og Annex 1. Erfaring med kvalitetssystemer som avvikshåndtering, CAPA, endringskontroll, internrevisjon, risikostyring og opplæringssystemer. Erfaring med dokumentstyring og utarbeidelse av GMP-prosedyrer. Erfaring med å analysere og visualisere kvalitetsdata ved bruk av Excel, inkludert pivottabeller, grafer og dashboards. Gode analytiske evner og en strukturert tilnærming til problemløsning. Gode samarbeidsevner og evne til å kommunisere på tvers av fagområder. Flytende norsk og engelsk, både muntlig og skriftlig. Det er en fordel om du har erfaring med Kvalitetsrelaterte prosesser i SAP, og godkjenning av artwork, etiketter eller emballasjemateriell. LEAN, Operational Excellence eller kontinuerlig forbedringsarbeid. Risikostyring og revisjoner i regulerte miljøer. Strukturerte problemløsningsmetoder.

Inclusion & Diversity statement

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.

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.

Additional Information

Relocation Assistance Provided: No. At GE HealthCare, we see possibilities through innovation. We’re partnering with our customers to fulfill healthcare’s greatest potential through groundbreaking medical technology, intelligent devices, and care solutions. Better tools enabling better patient care. Together, we are not only building a healthier future but living our purpose to create a world where healthcare has no limits.