Bristol Myers Squibb
Sr. Specialist, External Manufacturing Quality Assurance
Bristol Myers Squibb, Indianapolis, Indiana, us, 46262
Sr. Specialist, External Manufacturing Quality Assurance
Join to apply for the
Sr. Specialist, External Manufacturing Quality Assurance
role at
Bristol Myers Squibb . Company Overview
RayzeBio, a Bristol Myers Squibb company, is headquartered in San Diego, CA and focuses on improving the survival of people with cancer by harnessing targeted radioisotopes. The company develops innovative drugs against solid tumor targets under the leadership of an experienced entrepreneurial team, aiming to be the global leader in radiopharmaceuticals. Summary
The Senior Specialist, External Manufacturing Quality Assurance is responsible for quality oversight of the Contract Manufacturing Organization (CMO) operations for Radiopharmaceutical products in accordance with business agreements, regulatory standards, and RayzeBio procedures. The scope includes clinical and commercial products as well as Standard of Care products, in accordance with RayzeBio policies, standards, procedures and global cGMP. Job Responsibilities
Support Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations. Develop and implement policies and procedures for CMO compliance, including development of applicable Quality Agreements, Quality Business Processes, Product Disposition, and Quality Event Resolution in accordance with organizational strategy and business realities. Ensure approved quality systems are established and maintained to RayzeBio's quality standards and regulatory requirements. Partner closely with CMOs and RayzeBio's leadership team to ensure consistent and collaborative messaging to external manufacturing partners. Work cross functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners. Provide communication, support, and guidance to manufacturing partners and within the QA team. Effectively communicate issues, risks and proposed solutions within the organization. Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation related to externally manufactured product. Identify and report discrepancies from required work practices or procedures to management. Make sound decisions by exercising judgment within generally defined practices and policies and apply appropriate notification to management as appropriate. Participate as requested in the response team for audits and inspections by health authorities. Education and Experience
BS/MS degree in a science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred. Minimum of 5 years' experience in quality assurance and/or compliance roles in the pharmaceutical industry. Hands‑on experience with QA oversight of contract manufacturing organizations is highly desired, but applicable quality experience will be considered. Skills and Qualifications
Expertise in GMP, Quality, material and product disposition. Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with quality risk management principles. Detail‑oriented with demonstrated applications in problem solving and decision‑making abilities with moderate oversight from management. Strong project management skills and organizational ability to follow projects through to completion. Team player who can work independently to achieve objectives in a fast‑paced environment. Excellent verbal and written communication skills. Audit and inspection management experience. 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 FDA, EMA, or other regulatory authority. Demonstrated leadership, interpersonal, communication, and motivation skills. Previous work responsibility requiring 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 30 pounds. Specific vision abilities required by this job include close vision and distance vision. Work Environment
The noise level in the work environment is usually moderate. This position may require work outside of normal working hours or on weekends. Compensation Overview
Indianapolis, IN: $82,236 - $99,650. Additional incentive cash and stock opportunities (based on eligibility) may be available. Final, individual compensation will be decided based on demonstrated experience. Benefits
Health Coverage: Medical, pharmacy, dental and vision care. Wellbeing Support Programs such as BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well‑being and Protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees). Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non‑Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays. Additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. 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 a supportive culture, promoting global participation 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 an 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. Supporting People With Disabilities
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/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. R1595142 Sr. Specialist, External Manufacturing Quality Assurance
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Join to apply for the
Sr. Specialist, External Manufacturing Quality Assurance
role at
Bristol Myers Squibb . Company Overview
RayzeBio, a Bristol Myers Squibb company, is headquartered in San Diego, CA and focuses on improving the survival of people with cancer by harnessing targeted radioisotopes. The company develops innovative drugs against solid tumor targets under the leadership of an experienced entrepreneurial team, aiming to be the global leader in radiopharmaceuticals. Summary
The Senior Specialist, External Manufacturing Quality Assurance is responsible for quality oversight of the Contract Manufacturing Organization (CMO) operations for Radiopharmaceutical products in accordance with business agreements, regulatory standards, and RayzeBio procedures. The scope includes clinical and commercial products as well as Standard of Care products, in accordance with RayzeBio policies, standards, procedures and global cGMP. Job Responsibilities
Support Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations. Develop and implement policies and procedures for CMO compliance, including development of applicable Quality Agreements, Quality Business Processes, Product Disposition, and Quality Event Resolution in accordance with organizational strategy and business realities. Ensure approved quality systems are established and maintained to RayzeBio's quality standards and regulatory requirements. Partner closely with CMOs and RayzeBio's leadership team to ensure consistent and collaborative messaging to external manufacturing partners. Work cross functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners. Provide communication, support, and guidance to manufacturing partners and within the QA team. Effectively communicate issues, risks and proposed solutions within the organization. Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation related to externally manufactured product. Identify and report discrepancies from required work practices or procedures to management. Make sound decisions by exercising judgment within generally defined practices and policies and apply appropriate notification to management as appropriate. Participate as requested in the response team for audits and inspections by health authorities. Education and Experience
BS/MS degree in a science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred. Minimum of 5 years' experience in quality assurance and/or compliance roles in the pharmaceutical industry. Hands‑on experience with QA oversight of contract manufacturing organizations is highly desired, but applicable quality experience will be considered. Skills and Qualifications
Expertise in GMP, Quality, material and product disposition. Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with quality risk management principles. Detail‑oriented with demonstrated applications in problem solving and decision‑making abilities with moderate oversight from management. Strong project management skills and organizational ability to follow projects through to completion. Team player who can work independently to achieve objectives in a fast‑paced environment. Excellent verbal and written communication skills. Audit and inspection management experience. 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 FDA, EMA, or other regulatory authority. Demonstrated leadership, interpersonal, communication, and motivation skills. Previous work responsibility requiring 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 30 pounds. Specific vision abilities required by this job include close vision and distance vision. Work Environment
The noise level in the work environment is usually moderate. This position may require work outside of normal working hours or on weekends. Compensation Overview
Indianapolis, IN: $82,236 - $99,650. Additional incentive cash and stock opportunities (based on eligibility) may be available. Final, individual compensation will be decided based on demonstrated experience. Benefits
Health Coverage: Medical, pharmacy, dental and vision care. Wellbeing Support Programs such as BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well‑being and Protection: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees). Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non‑Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays. Additional time off may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. 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 a supportive culture, promoting global participation 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 an 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. Supporting People With Disabilities
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/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. R1595142 Sr. Specialist, External Manufacturing Quality Assurance
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