- Bachelors degree or higher preferred
- Minimum 5-7 years in GxP (GMP, GLP, GCP) pharmaceutical environment or other regulated industry in progressive responsibility roles. Highly desirable to have a minimum of 6 years of Quality 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 is 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 managing quality operations teams preferred
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Manager, Quality Assurance Operations - Indianapolis, United States - RayzeBio
Description
Job Title: Manager, Quality Assurance Operations
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.
Job Description
This position is responsible for the tactical oversight and maintenance of the Quality operations and batch review for RayzeBio internal and external operations. This includes managing the release of GMP products produced by RayzeBio and RayzeBio CMDOs and supporting those manufacturing functions. This position will report to the Head of GMP Quality and oversee GMP quality operations at RayzeBio Indianapolis.
Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
Ability to gown and work in a cleanroom environment supporting manufacturing activities
Quality support of RayzeBio and CDMO manufacturing including managing all batch review
Coordinate with QP for European release of batches
Support Deviations and Investigations; Corrective and Preventive Actions; Product Complaints; and Change Control
Assist in developing reports quality/KPI metrics to support GxP activities and management review.
Responsible for establishing, expanding, and maintaining RayzeBio GMP compliance program and building a positive quality culture at RayzeBio Indianapolis.
Evaluate, author, and/or review operating procedures (e.g. policies, SOPs, etc.), and perform other activities in support of quality operations.
Supervise 1-3 direct reports
Education and Experience:
Physical Demands
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and distance vision.
This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.
Work Environment
The noise level in the work environment is usually moderate.
