Sr. Specialist - Indianapolis, IN

Sr. Specialist - Indianapolis, IN

Attention Military Affiliated Job Seekers - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please follow the next steps.

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.

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

Bachelors 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.