Manager, GMP Inspection Management

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 Manager, GMP Inspection Management provides management of activities for Site Quality Operations in accordance with Rayze Bio policies, standards, procedures and global cGMPs. In addition, the role will be responsible for the Self-Inspection Program, Pre-Licensure Inspection Readiness Audits, QP audits, and Health Authority Inspections.

Job Responsibilities

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

* Leads site inspection readiness efforts about preparing the Indianapolis site for health authority inspections and internal corporate audits.

* Develop and manage the Inspection Readiness annual plan, including identification of anticipated inspections.

* Participates as a core team member in any corporate or health authority inspections and leads cross functional teams to develop responses, tracking the commitments to completion.

* Responsible Rayze Bio Self-Inspection Program. May conduct audits of Rayze Bio departments relative to Rayze Bio policies and procedures as well as the relevant Health Authority requirements.

* Leads Regulatory Surveillance activities, including identifying impacted functions, driving impact assessments and proactive action plans

* Provides compliance expertise and guidance to the site on applicable regulatory, cGMP and corporate requirements.

* Supports regulatory agency correspondence and filing submission activities.

* Leads Fact Finding deliverables for significant events and supports Field Alert Reporting submissions as required.

* Leads APQR document coordination and authoring support for site

* 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.

* Provides oversight to identify and implement changes that lead to realization of long-term department and company goals.

* Other QA specific responsibilities as assigned by QA management

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 5-7 years of work experience in Quality Assurance and minimum 4 years of direct QA experience in leading/hosting/conducting GMP audits/inspections.

* Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired.

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

* Knowledge and proven experience in hosting/facilitating FDA, EMA, or other regulatory authority inspections.

* 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 compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the…