Sr. Specialist, External Manufacturing Quality Assurance

Sr. Specialist, External Manufacturing Quality Assurance

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Rayze Bio, 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.

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 Rayze Bio procedures. The scope includes clinical and commercial products as well as Standard of Care products, in accordance with Rayze Bio policies, standards, procedures and global cGMP.

• 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 Rayze Bio's quality standards and regulatory requirements.
• Partner closely with CMOs and Rayze Bio'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.

• 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.

• 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…