Director, Quality Operations, Radiopharmaceutical Manufacturing - Bristol Myers Squibb
Indianapolis, IN
About the Job
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
RayzeBio is seeking a Director of Quality Operations at our state-of-the-art Radiopharmaceutical Manufacturing Facility in Indianapolis, IN (USA). This role will be responsible for overseeing all Quality aspects related to GMP production of Isotopes and the RayzeBio pipeline of radiopharmaceutical drug products for global clinical trial and commercial use.
This role will partner with external and internal stakeholders driving Quality Systems at the Indianapolis site. The Director of Quality Operations will drive a culture of Quality and ensure GMP compliance and the successful and timely execution of day-to-day production operations supporting global distribution of isotope and drug products.
Additional responsibilities include establishing and managing Quality Operational KPI's, supporting and driving operational improvements within the Quality organization. The Director of Quality Operations will support the sites transition for clinical to commercial operations and be a key Quality leader supporting operational readiness for QP, PAI and other Regulatory Authority quality audits. This role will drive a site culture of Quality with a patient first mindset.
Key Responsibilities:
Essential duties and responsibilities include the following. Other duties may be assigned.
+ Responsible for Quality Operations oversight and day-to-day Quality management related to isotope and Radiopharmaceutical drug product manufacturing at the Indianapolis facility.
+ Ensure adherence to applicable GMP regulations and company policies and procedures.
+ Collaborate with other business leaders across the organization to support the development, continuous improvement and lifecycle management of GMP policies and procedures.
+ Provide leadership and build an exceptional Quality Operations team.
+ Champion and foster a positive and quality compliant culture with a patient safety mindset.
+ Lead the implementation of site readiness for FDA Pre-Approval Inspection Pre-license inspection.
+ Support compliance audits and regulatory inspections by competent regulatory authority (e.g., FDA, EMA, PMDA, etc.).
+ Establish and manage Quality Operational KPI's and related metrics.
+ Work collaboratively with Leads from Facilities and Engineering, Manufacturing, IT, Clinical Operations, Logistics, and MS&T, to ensure the ongoing qualified and operational readiness for commercial manufacturing at the facility.
+ Support the implementation of corporate initiatives and ensure success toward annual corporate goals and objectives.
Education and Experience:
+ BS/MS in relevant Science or Engineering discipline and 10+ years of experience in building, managing and leading Quality Operations teams
+ Proven expertise in GMP operations and compliance for global clinical trial and commercial injectable or radiopharmaceutical operations required.
+ Strong background in US/EU regulations with regulatory agency inspection experience required.
+ Experience implementing and improving GMP Quality systems related to commercial manufacturing operations is required
+ Demonstrated Quality leadership through a partnership approach with manufacturing and other Quality teams to enable high quality and compliant product distribution to patients is required
+ Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
+ Demonstrated excellence in written and verbal communication
+ Previous experience in a commercial GMP parenteral facility, previous Radiopharma experience a plus
Skills and Qualifications:
Beyond having the requisite experience and qualifications, a successful candidate will have a proven history of team and personnel leadership with high levels of self-motivation, adaptability, critical thinking, analysis, and creative problem-solving. This is a fast-paced position within a fast-paced organization, so the ability to come in and hit the ground running is critical for success in the role.
#LI-ONSITE #Rayzebio
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.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1588610
Updated: 2025-02-28 03:36:09.876 UTC
Location: Indianapolis-IN
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
RayzeBio is seeking a Director of Quality Operations at our state-of-the-art Radiopharmaceutical Manufacturing Facility in Indianapolis, IN (USA). This role will be responsible for overseeing all Quality aspects related to GMP production of Isotopes and the RayzeBio pipeline of radiopharmaceutical drug products for global clinical trial and commercial use.
This role will partner with external and internal stakeholders driving Quality Systems at the Indianapolis site. The Director of Quality Operations will drive a culture of Quality and ensure GMP compliance and the successful and timely execution of day-to-day production operations supporting global distribution of isotope and drug products.
Additional responsibilities include establishing and managing Quality Operational KPI's, supporting and driving operational improvements within the Quality organization. The Director of Quality Operations will support the sites transition for clinical to commercial operations and be a key Quality leader supporting operational readiness for QP, PAI and other Regulatory Authority quality audits. This role will drive a site culture of Quality with a patient first mindset.
Key Responsibilities:
Essential duties and responsibilities include the following. Other duties may be assigned.
+ Responsible for Quality Operations oversight and day-to-day Quality management related to isotope and Radiopharmaceutical drug product manufacturing at the Indianapolis facility.
+ Ensure adherence to applicable GMP regulations and company policies and procedures.
+ Collaborate with other business leaders across the organization to support the development, continuous improvement and lifecycle management of GMP policies and procedures.
+ Provide leadership and build an exceptional Quality Operations team.
+ Champion and foster a positive and quality compliant culture with a patient safety mindset.
+ Lead the implementation of site readiness for FDA Pre-Approval Inspection Pre-license inspection.
+ Support compliance audits and regulatory inspections by competent regulatory authority (e.g., FDA, EMA, PMDA, etc.).
+ Establish and manage Quality Operational KPI's and related metrics.
+ Work collaboratively with Leads from Facilities and Engineering, Manufacturing, IT, Clinical Operations, Logistics, and MS&T, to ensure the ongoing qualified and operational readiness for commercial manufacturing at the facility.
+ Support the implementation of corporate initiatives and ensure success toward annual corporate goals and objectives.
Education and Experience:
+ BS/MS in relevant Science or Engineering discipline and 10+ years of experience in building, managing and leading Quality Operations teams
+ Proven expertise in GMP operations and compliance for global clinical trial and commercial injectable or radiopharmaceutical operations required.
+ Strong background in US/EU regulations with regulatory agency inspection experience required.
+ Experience implementing and improving GMP Quality systems related to commercial manufacturing operations is required
+ Demonstrated Quality leadership through a partnership approach with manufacturing and other Quality teams to enable high quality and compliant product distribution to patients is required
+ Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
+ Demonstrated excellence in written and verbal communication
+ Previous experience in a commercial GMP parenteral facility, previous Radiopharma experience a plus
Skills and Qualifications:
Beyond having the requisite experience and qualifications, a successful candidate will have a proven history of team and personnel leadership with high levels of self-motivation, adaptability, critical thinking, analysis, and creative problem-solving. This is a fast-paced position within a fast-paced organization, so the ability to come in and hit the ground running is critical for success in the role.
#LI-ONSITE #Rayzebio
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.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1588610
Updated: 2025-02-28 03:36:09.876 UTC
Location: Indianapolis-IN
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Source : Bristol Myers Squibb