Senior Supplier Quality Auditor Indianapolis - RayzeBio - IN R1600772 Posted ago

Position: Senior Supplier Quality Auditor Indianapolis - RayzeBio - IN R1600772 Posted a month ago
Location: Indianapolis

## Senior Supplier Quality Auditor 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:  Senior Supplier Quality Auditor is responsible for leading the planning, execution, and reporting of supplier and service provider audits to ensure compliance with applicable cGMP/GxP regulations, internal procedures, and quality agreements. This role provides independent quality oversight of critical suppliers, supports supplier qualification and monitoring programs. 10-15% of travel may be required.
** Job Responsibilities
** Essential duties and responsibilities include the following. Other duties may be assigned.
* Plan, schedule, and conduct onsite and remote audits of suppliers and external service providers in accordance with the approved supplier audit program.
* Evaluate supplier compliance with applicable regulatory requirements (e.g., FDA, EMA, ICH), internal SOPs, and executed quality agreements.
* Document supplier audit observations and collaborate with suppliers and internal stakeholders to develop appropriate and effective CAPAs.
* Track supplier CAPAs to closure and verify timely implementation and effectiveness.
* Maintain complete and accurate supplier audit records and ensure timely communication of audit results and risk assessments.
* Support regulatory inspections and inspection readiness activities related to supplier oversight and audit programs.
* Provide guidance and training to suppliers and internal teams on supplier audit processes and GxP compliance expectations.
* Participate in continuous improvement initiatives related to supplier quality oversight and supplier audit processes.
* Domestic travel to supplier sites is required.
** Education and Experience
*** Bachelor’s degree in Life Sciences, Chemistry, or a related field or equivalent experience.
* Minimum of 7 years of experience in quality assurance, auditing, or supplier management within the pharmaceutical, biotechnology, or cGMP industry.
* Auditing experience within regulated biotech/pharma industry or equivalent in a GxP-regulated environment, with at least 3 years in auditing or quality assurance.
* Strong knowledge of global GxP regulations and standards (e.g., 21 CFR Parts 11, 210, 211; Eudra Lex Volume 4; ICH Guidelines).
* Experience conducting audits across GMP, GLP, and/or GCP domains.
* Demonstrable ability to identify systemic quality and compliance risks
** Skills and Qualifications
*** Proven ability to identify systemic quality and compliance risks
* Excellent analytical, communication, and report-writing skills.
* Ability to work independently and manage multiple priorities.
* Ability to utilize AI tools to enhance individual productivity and quality of work
* Strong technical writing skills for audit reports and regulatory documentation
* Sound quality judgment and ability to work independently
* Strong communication and stakeholder management skills
* Uses AI tools to enhance individual productivity and quality of work
** Work
* *** Environment
* * The noise level in the work environment is usually moderate.#LI-ONSITE
* 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: $96,148 - $116,508  The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive…