Director of Quality

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

We are a growing Animal Health company that specializes in the manufacture of vaccines and nutrition solutions. Our product portfolio is expanding and we are looking for a Director of Quality to provide oversight of our Quality Assurance (QA), Quality Control (QC) and Quality Management Systems (QMS) operations.

The successful candidate is passionate about team building, has successfully led vaccine tech transfers to enable launch, made process improvements within a QMS, and used creative problem solving to reduce roadblocks and delays. They must have experience with QA, QC, QMS, and in-depth knowledge of USDA regulatory guidelines and submission protocols. This individual is strategic, with good experience at high-level project management and communication.

Located in Lincoln, Nebraska, we offer clear autonomy to build and grow the organization, making a lasting impact in the way we do business!

We offer excellent benefits, salary in the range of $135k to $165k plus substantial annual bonus.

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.

Requirements

• Minimum of 10 years’ experience working in Quality within an animal health vaccine manufacturing environment
• 8 years of experience managing personnel within Quality departments (QA and or QC)
• Extensive experience working with USDA or FDA compliance
• Bachelor’s degree in Microbiology, Biology, Immunology or related field
• Ability to travel in the U.S. up to 30% of the year