Quality Assurance Associate (Exuma Biotech)
Location: Cayman Islands
Exuma Biotech, an affiliate company to F1 Oncology, is looking for another individual to share our passion for making a lasting difference in the fight against cancer.
This position will support the Associate Director, CMC Quality in perform planning, controlling, monitoring and reporting for assigned projects and keeps the Chemistry, Manufacturing, and Controls (CMC) and Quality oversight of the Exuma Global Quality Management System.
Why Join Us?
Exuma Biotech is a clinical-stage biotechnology company committed to discovering, developing and commercializing CAR-T therapies for the treatment of cancer. The company has rapidly built its core technologies with a growing global presence with operations in China (Shanghai and Shenzhen), and Grand Cayman, and affiliated with F1 Oncology in the US with sites in West Palm Beach and San Diego.
This is a full-time position working with a great team and with excellent benefits associated with Grand Cayman.
Some of the responsibilities:
- Assist in Maintaining Exuma Biotechnology Global Quality Documentation System
- Maintain Global Controlled Document Area and ensure affiliate sites adhere to Global Document Control Procedures
- Develop and implement a file migration plan to integrate site-controlled documents in the Global Controlled Document System
- Support document control room and GxP document lifecycle management activities such as filing, archiving, providing execution copies, etc. as per Exuma Global Quality System Procedures
- Assist in managing Global Training Program
- Perform group training sessions as needed
- Assist with Vendor Qualifications
- Participate in Vendor Audits/review of vendor quality documentation as needed
- Participate in Global Quality Meetings on a weekly basis
- Support Global and Local Site Quality Assurance in the preparation and execution of regulatory and third-party inspections
- Up to 10% travel required
We are looking for candidates with the following background and education:
- Bachelor’s degree from an accredited institution required
- Post-Graduate Diploma/Certification in Quality Assurance preferred
- At least three (3) years of industry experience or equivalent experience in related industry required
- Biopharmaceutical CMC experience preferred
- Ability to illustrate complex issues and to evaluate them critically as well as to navigate a goal-orientated decision process
- Possesses planning and organizational skills
- Able to manage a number of projects simultaneously
- Has experience in multicultural environments
- Bilingual English/Mandarin fluency a strong asset
- Willing to travel
- Experience working in Oncology or Immuno-oncology field – Preferred
- Proven ability to work efficiently and independently
- Strategic thinker, self-starter, and results-oriented
To apply or obtain additional information, contact: firstname.lastname@example.org with your resume and cover letter (cover letter required for application)