Sr. Specialist Indianapolis, IN

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Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here uniquely interesting work happens every day in every department. From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives.
RayzeBio a Bristol Myers Squibb company is a dynamic biotechnology company headquartered in San Diego CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team RayzeBio aims to be the global leader in radiopharmaceuticals.

Summary

The Senior Specialist External Manufacturing Quality Assurance is responsible for quality oversight of the Contract Manufacturing Organization (CMO) operations for Radiopharmaceutical products in accordance with business agreements regulatory standards and RayzeBio procedures. The scope includes clinical and commercial products as well as Standard of Care products in accordance with RayzeBio policies standards procedures and global current Good Manufacturing Practice (cGMP).

The Senior Specialist provides Quality support and oversight for CMO operations and disposition activities including review and approval of Deviations CAPAs Change Controls documents Batch Records and Lot Disposition. This person will also interact with the Qualified Person (QP) as needed to facilitate release of EU doses.

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

Support Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications including all related deviations.

Develops and implements policies and procedures for CMO compliance including development of applicable Quality Agreements Quality Business Processes Product Disposition and Quality Event Resolution in accordance with organizational strategy and business realities.

Ensures approved quality systems are established and maintained to RayzeBios quality standards and regulatory requirements.

Partner closely with CMOs and RayzeBios leadership team to ensure consistent and collaborative messaging to external manufacturing partners.

Work cross functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners. Provide communication support and guidance to manufacturing partners and within the QA team. Effectively communicatee issues risks and proposed solutions within the organization.

Assist with and provide QA approval of investigations CAPAs change controls validation documentation and other related GMP documentation related to Externally Manufactured product.

Identify and report discrepancies from required work practices or procedures to management.

Make sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.

Participate as requested in the response team for audits and inspections by health authorities.