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Operations Project Investigation Expert at Legend Biotech
As an Operations Project Investigation Expert, you'll dive deep into the heart of our manufacturing process, sleuthing out the causes of complications and human errors. Your mission? To ensure our life-saving treatments are safe and reach patients on time. If you're passionate about quality and eager to make a mark in the exciting field of personalized medicine, this is the perfect role for you!
Job
As an Operations Project Investigation Expert, you will have a challenging and varied set of duties. Here's what you'll do:
- Conduct operational investigations: You will conduct in-depth investigations to quickly identify and resolve the causes of incidents due to human error in our production process. As a result, you ensure safe and timely product releases. You also implement robust investigation methods and train the team to efficiently handle quality investigations.
- Quality and compliance: You ensure that all investigations meet the highest GMP standards and regulatory requirements. You take the lead in investigating and reporting deviations and support other departments in deviation investigations. You apply and support corrective and preventive actions (CAPAs).
- Act as SPOC for regulatory agencies: You will act as the main contact for regulatory agencies during inspections and defend investigation strategies and reports with conviction.
- Drive continuous improvements: You will maintain and lead the research dashboard, support QEM systems and implement process improvements based on lessons learned.
- Build strong partnerships: You will build lasting connections with various stakeholders to ensure the smooth handling of investigations.
Profile
Education: You have a master's degree in (bio)engineering, science, pharmacy or another related field of study or you are equivalent through experienc
Experience: You have at least 3 years of project execution experience within an operational cGMP or ATMP environment in the biotech or pharmaceutical industry. Previous experience in manufacturing, quality or engineering is essential.
Languages: You are proficient in Dutch and English, with strong written and oral communication skills.
Strengths:You are an enthusiastic team player, eager to learn and willing to solve complex technical and scientific challenges. You have excellent organizational, analytical and scientific writing skills. Your proactive, positive and flexible attitude makes it easy to build strong partnerships.
Expertise: You have knowledge of cGMP regulations and FDA/EU guidelines related to ATMPs. You have experience with risk assessment and root cause analysis.
Benefits
- A job with impact that directly contributes to the well-being of patients worldwide.
- 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 permanent contract 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.
Company profile
Legend Biotech is a global biotechnology company dedicated to developing, manufacturing and commercializing innovative and life-saving cell therapies, including treatments for hard-to-treat diseases like cancer.
Since our founding in 2014, we have expanded to over 2,000 employees across six global manufacturing facilities, with our headquarters in New Jersey.
In Ghent, we specialize in producing advanced CAR-T therapies for multiple myeloma, in partnership with Johnson & Johnson.
