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
1. Lead multiple manufacturing investigations, establishing strategies to quickly drive to root cause and meet critical release windows.
2. Oversee investigation processes and standards, supporting CAPA implementation related to manufacturing processes.
3. Act as the company’s representative during regulatory inspections, defending investigation strategies and responses to observations.
4. Strengthen partnerships with various stakeholders to ensure smooth alignment in handling complex investigations.
5. Apply expertise in scientific and cGMP principles to improve product quality, safety, and efficacy.
6. Mentor and train team members, fostering a culture of learning and development.
Your profile
Education :
7. Minimum of a Master’s degree in Engineering, Science, Pharmacy, or a related field.
Experience :
8. 8–10 years of experience in a cGMP environment within the biotech/biopharma industry.
9. Experience with cell and gene therapy is a plus.
Languages:
10. Fluent in English (knowledge of Dutch is a plus).
Strengths :
11. Excellent scientific writing skills and analytical thinking.
12. Proven experience in independently leading quality investigations.
13. Strong communication skills and the ability to build relationships.
14. Positive, proactive, and results-driven mindset.
15. Strong organizational and project management skills.
Expertise :
16. Deep knowledge of cGMP regulations and ATMP guidelines.
17. Experience with root cause analysis and risk assessment methodologies.
18. Experience with advanced data analysis and presenting trends and findings.
What you'll get in return
19. A meaningful job with an excellent work-life balance.
20. A supportive and innovative work environment.
We value and encourage learning and personal development.
21. The opportunity to work with people from all over the world.
22. 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.
23. 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.
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