Sr. Specialist, External Manufacturing Quality Assurance

Senior Specialist, External Manufacturing Quality Assurance

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. 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.

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.

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 current Good Manufacturing Practice (cGMP). The Senior Specialist provides Quality support and oversight for CMO operations and disposition activities including review and approval of Deviations, CAPAs, Change Controls, documents, Batch Records, and Lot Disposition. This person will also interact with the Qualified Person (QP) as needed to facilitate release of EU doses.

Job Responsibilities

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

• 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.
• Develops and implements 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.
• Ensures 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 applies 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 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, 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 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 - RayzeBio - IN : $82,236 - $99,650 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 employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https : / / careers.bms.com / life-at-bms / . Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following : Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility / infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.