Senior Manager - QA Operations

At Rayze Bio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, Rayze Bio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer.

Here, you'll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact-on our science, on our teams, and most importantly, on patients. Learn more about Rayze Bio:

The Senior Manager, Operations QA is a key role in the Quality Assurance team at the Rayze Bio Indianapolis manufacturing site. This is a people manager position with supervisory responsibilities for up to 8 direct reports. The Operations Quality Assurance team is responsible for Quality collaboration and GMP/GDP oversight of operations at CDMOs and at Internal site operations, including but not limited to manufacturing, testing, packaging, labeling, and warehouse operations, including incoming material management.

The Senior Manager, Operations Quality Assurance, Rayze Bio is responsible for the cGMP/GDP activities at CDMOs and at the Indianapolis site in accordance with Rayze Bio policies, standards, procedures, and the regulatory requirements (US, EU, ICH etc.). Functional responsibilities include ensuring operational compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues.

The Senior Manager, Operations Quality Assurance role is located in Indianapolis, IN, and reports to the Site Quality Lead of the Rayze Bio Indianapolis manufacturing site.

Key Responsibilities

* Provide leadership to ensure routine Operations Quality oversight and to ensure collaborative triages of unexpected events within the Manufacturing, Quality Control Labs, and Supply Chain operational areas and systems.

* Have a comprehensive understanding of Radio-Pharma manufacturing processes to enable real-time decision-making.

* Advanced ability to synthesize information from multiple sources, interpret problems and effectively communicate to cross-functional management in a clear, brief, and accurate manner.

* Respond to complex/critical issues and build a consensus of understanding with subject-matter experts for product impact and justification to stop/continue manufacturing

* Serve as a subject matter expert supporting others to navigate the Rayze Bio quality management system including but not limited to deviation and CAPA action management, interim production controls, disposition decisions, and batch record management.

* Evaluate, author, and/or review operating procedures (e.g., policies, SOPs, Wis) and perform other activities in support of quality operations.

* Provide direction and timely guidance to the staff regarding the handling and resolution of cGMP events which may be a part of deviations, batch record exceptions, and other quality operational challenges.

* Accountable for the performance/delivery of the QA field quality organization, including oversight of the "QA on-the-floor" systems and programs that enable the highest quality and the quickest delivery of QA cGMP tasks.

* Develop and implement standard-work for team-members that balances on-floor support for non-routine events, routine quality assurance work, and stretch/development project work.

* Assist in developing quality KPI/metrics to support GxP activities and/or for management reviews

* Responsible for establishing, expanding, and maintaining Rayze Bio GMP compliance program and building a positive quality culture at Rayze Bio Indianapolis site.

* Champion a culture that embraces psychological and physical safety of employees in the work environment.

* Champion a culture of teamwork, communication, and continuous improvement focused on defining problem statements, driving initial investigative efforts, and actioning solutions to reduce recurrence.

* Proactively identify and address quality risks and critical issues, drive mitigations with the aid of Field Quality Staff and cross-functional partners and escalate to senior management as needed.

* Lead walkthroughs with peers or QA team-members to identify and remediate operational or quality issues.

* Review and interpret the technical conclusions of a record/investigation and provide constructive feedback.

* Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge

* Regularly spend time coaching and mentoring operators and Field QA specialists while on the manufacturing floor.

* Interview, hire, coach, motivate, and develop exceptional staff. Set performance objectives and development plans.…