Job Title:
Manager, Quality Assurance Systems
Location:
Indianapolis
Background
RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC) and breast cancer. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
Summary
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 in the GMP spectrum. This position will report to the Head of GMP Quality and oversee GMP quality systems at RayzeBio Indianapolis.
Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
· Responsible for establishing, expanding, and maintaining RayzeBio GMP compliance program at RayzeBio Indianapolis.
· Oversee and coordinate quality issues cross-functionally
· 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.
· 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.
· Supervise 1-3 direct reports
Education and Experience:
Bachelor's degree or higher
Minimum 5-7 years in GxP (GMP, GLP, GCP) pharmaceutical or other regulated environment demonstrating progressive increase in responsibility. 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
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 implementing and developing quality systems preferred
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