We are seeking an experienced and motivated Quality Assurance Associate Director/Director.
This position is responsible for the tactical oversight and maintenance of the Quality Management System for RayzeBio internal and external operations. This includes establishment, continuous improvement, and ensuring the consistent implementation of global quality system policies across the GxP spectrum. In addition to broad quality system implementation and support, the role will assist in clinical trial oversight activities and GMP clinical manufacturing operations. This position will report to the VP of Regulatory Affairs and Quality and oversee GxP quality functions within RayzeBio.
Essential duties and responsibilities include the following. Other duties may be assigned.
- Responsible for establishing, expanding, and maintaining RayzeBio GxP compliance program.
- Implements Quality Systems at RayzeBio including implementation of electronic systems as needed.
- Maintain and Provide Oversight of Quality Assurance Systems including: Deviations and Investigations; Corrective and Preventive Actions; Product Complaints; Change Control; Document Control; and GxP Training
- Manage internal audit program, audit schedule, and approved vendor list. May perform both internal and external audits.
- Works closely with clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement.
- May serve as QA Lead for assigned clinical stage programs, ensuring balance between operational timelines and compliance requirements. Ensures Clinical Trial Materials (CTMs) are properly tested and released, including review of batch records, COAs, and associated release data of GMP products.
- Evaluate, author, and/or review operating procedures (e.g. policies, SOPs, etc.), and perform other activities in support of an integrated cross-functional quality management system (QMS).
- Assist in developing reports quality/KPI metrics to support GxP activities and management review.
Education and Experience:
- Bachelor ’s degree or higher
- Minimum 10 years in GxP (GMP, GLP, GCP) pharmaceutical environment in progressively responsible Quality roles. Highly desirable to have a minimum of 6 years of Quality Systems experience.
- Solid understanding of US and European regulations including application in the day to day environment
- Previous experience working with FDA and participating in regulatory agency inspections
- Ability to successfully solve challenging issues, critical thinking, and detail oriented
- Strong interpersonal, verbal, and written communication skills
- Demonstrable record of strong leadership and teamwork in a cross-functional industry environment.
- Excellent written and verbal communication skills.
- Previous experience in a start-up company preferred.
- Highly organized, with the ability to multi-task and handle pressure well
- Meticulous with detail and precision
- Ability to think through a project or task of diverse complexity and execute independently from beginning to end
- Fully proficient in MS Office (Outlook, Word, PowerPoint, Excel, and Teams) and video conferencing
- Strong communication and interpersonal skills
- Should be assertive, proactive, professional, and confident
- Excellent professional ethics and integrity
- Flexibility to adapt in a cross-functional and dynamic start-up environment
Compensation: Competitive base salary with bonus, stock options, and full benefits
To apply please send CV to email@example.com