Manager, QA Compliance Indianapolis - RayzeBio - IN R1600399 Posted

Position: Manager, QA Compliance Indianapolis - RayzeBio - IN R1600399 Posted a day ago
Location: Indianapolis

## Manager, QA Compliance Indianapolis - Rayze Bio - INFind out how well you match with this jobAt 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:  Manager for QA Compliance 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 Change Controls Review Board, Complaints, Data Integrity, Quality Council, and other Quality metrics
** Job Responsibilities
** Essential duties and responsibilities include the following.  Other duties may be assigned as required.
* Implements and Manages the Change Control Quality System for all GMP activities and works with responsible cross functional areas ensure timely completion.
* Run the Change Control Review Boards, generate meeting minutes, follow up on action items and facilitate resolution when required.
* Communicates effectively with cross functional stakeholders on matters related to change control process.
* Implements and manages the necessary investigations and CAPA review boards at a timely manner.
* Responsible for the site Quality Council program and acts as Quality Council Lead
* Develops and Maintains Quality Metrics to monitor compliance
* Collaborates with stakeholders to develop appropriate actions to resolve quality system issues
* Leads site Data Integrity Program
* Responsible for complaints
* Participates as a core team member in any corporate or health authority inspections.
* 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 teams and cross-functional project teams and drives team performance and results. Contributes highly to departmental performance and quality initiatives; able to conceptualize impact of Quality initiatives in terms of cross-functional teams.
* Other QA specific responsibilities as assigned by QA management
* Applies AI to improve team execution and decision‐making
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* 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
* 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.
* 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…