Senior Associate, Quality Assurance - Innovative Gene Therapy
Orchard Therapeutics Limited is a global biotechnology company based in the UK, dedicated to bringing transformative gene therapies to children with severe and life-threatening orphan diseases. Orchard was founded in November 2015 and is rapidly expanding its operations in the EU, US and in other regions.
Reporting to the Manager, Document Control, the Senior Associate, Quality Assurance will be responsible for supporting the documentation activities in support of vector and drug product production and release. This position has interactions with various functional areas such as Cell Therapy Operations, Vector Manufacturing, Analytical Operations and Regulatory Affairs. The Senior Associate, Quality Assurance in Orchard Therapeutics is an essential role that ensures the efficient routing, approval, issuance, tracking and training on documentation.
- Ensures support with compliance and ongoing preparation for new projects
- Knowledge of vendor qualification and management
- Assist with internal training on QA Policies and Procedures
- Maintains equipment history files
- Establishes and maintains personnel training records and ensures training is current
- Assist in the generation and review of documents used in Manufacturing and Quality Control Testing for accuracy and completeness
- Prepares documentation for filing and maintains original documents and computerized files to support all documentation systems
- Ensures that records are secure, and retrievable throughout defined record retention periods
- Assigns deviation report numbers and maintain all approved reports
EXPERIENCE & SKILLS
The ideal candidate should have:
- Directly relevant experience with biologics or biotechnology derived products
- Ability to work independently and in a group on a variety of projects
- Ability to maintain a high degree of accuracy and attention to detail
- Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively
- Planning, organization and execution skills
- Strong problem-solving techniques and ability to make sound decisions
- Capable of assisting with analysis of trends and metrics that lead to improvement
- Must be able to multi-task and establish priorities
- Must work well with others and possess effective teaching abilities
- A thorough knowledge and understanding of Canadian, US FDA and European regulations (GMP), as well as experience with GLPs.
- Competency with electronic Quality Management Systems
- Proficiency in Microsoft Office (Word, Excel, Outlook, etc.)
- Excellent verbal and written communication skills required
- Strong presentation and negotiation skills required
- A Bachelor’s in Chemistry, Biochemistry, Biology, Pharmacy, or in a related discipline.
- A minimum of three (3) years knowledge and working experience with all aspects of quality assurance, which relate to a pharmaceutical development organization.