Senior Manager Manufacturing Investigations

Investigations I cGMP I CAPA I Inspections I Strategies I Compliance I English I Ghent | 1108332

Your new company

Legend Biotech is a global biotechnology company dedicated to developing, manufacturing, and commercializing innovative and life-saving cell therapies for the treatment of chronic and life-threatening diseases, such as cancer.

Your new role

Are you an experienced professional in the biotech/biopharma industry with a passion for quality investigations and process improvement?
Do you want to play a key role in ensuring product quality and safety in an innovative work environment?
Then this position as Senior Investigator is for you!

What can you expect?
As a Senior Investigator, you will be part of the Manufacturing Science and Technology (MSAT) team, responsible for leading complex investigations and implementing improvement strategies.
You will contribute to a strong quality culture by conducting risk assessments, leading process optimizations, and maintaining close collaborations with various stakeholders.
Additionally, you will support regulatory inspections and mentor team members.

Your Responsibilities
  • Lead multiple manufacturing investigations, establishing strategies to quickly drive to root cause and meet critical release windows.
  • Oversee investigation processes and standards, supporting CAPA implementation related to manufacturing processes.
  • Act as the company’s representative during regulatory inspections, defending investigation strategies and responses to observations.
  • Strengthen partnerships with various stakeholders to ensure smooth alignment in handling complex investigations.
  • Apply expertise in scientific and cGMP principles to improve product quality, safety, and efficacy.
  • Mentor and train team members, fostering a culture of learning and development.

Your profile

Education :
  • Minimum of a Master’s degree in Engineering, Science, Pharmacy, or a related field.
Experience :
  • 8–10 years of experience in a cGMP environment within the biotech/biopharma industry.
  • Experience with cell and gene therapy is a plus.
Languages:
  • Fluent in English (knowledge of Dutch is a plus).
Strengths :
  • Excellent scientific writing skills and analytical thinking.
  • Proven experience in independently leading quality investigations.
  • Strong communication skills and the ability to build relationships.
  • Positive, proactive, and results-driven mindset.
  • Strong organizational and project management skills.
Expertise :
  • Deep knowledge of cGMP regulations and ATMP guidelines.
  • Experience with root cause analysis and risk assessment methodologies.
  • Experience with advanced data analysis and presenting trends and findings.

What you'll get in return

  • A meaningful job with an excellent work-life balance.
  • A supportive and innovative work environment.
    We value and encourage learning and personal development.
  • The opportunity to work with people from all over the world.
  • A contract of indefinite duration and an attractive salary package complemented by many fringe benefits, such as additional statutory vacations, meal vouchers, group and hospitalization insurance, double vacation pay, an end-of-year and performance bonus.
  • Many fun and informal events.

What you need to do now


Are you interested in this role? Please click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.


#LI-DNI
Cliquez-ici pour accéder à la Politique de confidentialité de Hays, qui vous apportera des informations détaillées sur la manière dont nous utilisons et protégeons vos données personnelles et vos droits relatifs à ces données.

Résumé

Type d'emploi
CDI
Secteur
Healthcare & Medical
Lieu
Zwijnaarde
Spécialité
Life Sciences management
Salaire
A contract of indefinite duration and an attractive salary package complemented
Réf. :
1108332

Contacter un consultant

Contactez Audrey Melis, le consultant en charge de cette offre d'emploi, situé à Ghent
Hays Ghent, Kortrijksesteenweg 1084

Téléphone: 032027976

Numéro d'agrément 


VG 292/BUOSA W.INT.35 W.SO.35 


Brussels n° 00322-406-20121217 

Emplois similaires à Senior Manager Manufacturing Investigations

  • Productieleider interieur

    Productieleider interieur | Buggenhout | Winkelinrichtingen | Familiale werkomgeving | 1106334
    BuggenhoutUitdagende verloning aangevuld met o.a. wagen, verzekering...
  • Productiebeheerder

    Welle | Productiebeheerder | Ervaring | Administratief sterk | Insurance | 1107665
    WelleMarktconform loon met extralegale voordelen
  • PRODUCTIEVERANTWOORDELIJKE SPUITGIETEN

    People & coachen, organisatie, optimalisatie | technisch inzicht spuitgieten | regio Roeselare | ref 1108083
    Regio RoeselareMarktconform salarispakket en voordelen
  • Rechterhand productiemanager

    Regio Roeselare | Bachelor of master | Young Potential | Voedingsbedrijf | 1073851
    Roeselare€3000-€4500 + extralegale voordelen + firmawagen
  • Productieleider Beton

    Willebroek | Productieleider Beton | Technische of bouwkundige opleiding I Aansturen arbeiders | Rentabiliteit
    WillebroekAantrekkelijke loonpakket