Manager, Quality Systems

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:

Summary

The Quality Systems Manager is responsible for the establishment, maintenance, and continuous improvement of the QMS in accordance with Rayze Bio policies, standards, procedures and global cGMPs. This position will help ensure QMS systems are designed, setup, and function in a GMP-compliant manner

Job Responsibilities

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

* Maintains and provides oversight and support for activities using the various Quality Systems utilized at Rayze Bio such as the electronic Document Management System, electronic Quality Management System, or interfaces with laboratory systems.

* Collaborates with stakeholders to develop appropriate actions to resolve quality system issues

* Oversees quality system process support and compliance, not technical system administration.

* Provides input and quality approvals for validation documentation that supports enterprise systems or applicable site and/or globally owned systems.

* Reviews and approves documents, change controls, and protocols related to QMS systems

* Provides governance, oversight, and approval of deviation investigations related to quality systems.

* Drafts, reviews, and edits SOPs, process flow and other business documentation.

* Manages project activities and ensures appropriate team members are assigned to appropriate activities.

* Identifies and reports discrepancies from required work practices or procedures to management.

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

* Leads cross‑functional quality system initiatives and contributes to departmental quality objectives.

* Additional Quality Systems responsibilities consistent with role scope.

* Applies AI to improve team execution and decision‑making

Education and Experience:

* At minimum, a bachelor's degree in engineering or a life or physical science related field (including biology, biochemistry, chemistry) is required.

* Minimum 5 years of work experience in Quality Assurance

* Knowledge of US, EU and rest-of-world cGMP regulations and guidance.

* Demonstrated leadership, interpersonal, communication, and motivation skills.

* Excellent writing and oral communication skills are required.

* Previous work responsibility, which required a high degree of attention to detail.

* Well-practiced in exercising sound judgment in decision-making.

* Demonstrated prioritization and organization skills.

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.

The position may require occasional travel, but not more than 5%.

Work Environment

The noise level in the work environment is usually moderate.

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If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

Indianapolis - Rayze Bio - IN: $124,449 - $150,803

The starting…