Vaccine Quality Director & Compliance Leader

Blue Bully Recruiting LLC; Lincoln (NE); On-site; USD 135,000 - 165,000; Full time

Job summary

Unknown in Lincoln, Nebraska is seeking a Director of Quality to oversee QA, QC and QMS operations in an animal health vaccine manufacturing environment. The role emphasizes strategic leadership, regulatory knowledge (USDA/FDA), and cross-functional collaboration to enable launches.

The position offers autonomy to build and grow the organization, with a strong focus on quality improvements, risk-based decisions, and budgeting within quality operations. A substantial annual bonus is included.

Responsibilities

• Develop and execute the company’s biological quality strategy.
• Provide quality oversight for biological product manufacturing and testing.
• Ensure the effectiveness of the QMS by overseeing deviations, investigations, CAPA, change controls and related documentation.
• Ensure compliance with USDA and other global regulatory requirements.
• Lead quality risk assessments using risk-based methodologies.
• Work closely with Manufacturing, R&D, Regulatory Affairs, Supply Chain and Technical Operations to ensure product quality.
• Lead regulatory inspection readiness activities.
• Implement quality improvements based on trends, metrics and risk assessments.
• Manage budget and resources within quality operations.

Job description

Unknown in Lincoln, Nebraska is seeking a Director of Quality to oversee QA, QC and QMS operations in an animal health vaccine manufacturing environment. The role emphasizes strategic leadership, regulatory knowledge (USDA/FDA), and cross-functional collaboration to enable launches.

The position offers autonomy to build and grow the organization, with a strong focus on quality improvements, risk-based decisions, and budgeting within quality operations. A substantial annual bonus is included.