Director of Quality - Miami, United States - Leaman Life Sciences

Description

My client are seeking a seasoned Quality Director with extensive experience in animal testing facilities to ensure the highest standards of quality, compliance, and ethical practices within our organization.

As the Quality Director, you will play a critical role in overseeing quality management systems and continuous improvement initiatives to support our mission of advancing scientific research while prioritizing animal welfare.

Responsibilities:
Develop, implement, and maintain a comprehensive quality management system (QMS) tailored to the needs of animal testing facilities.
Establish and monitor quality metrics, key performance indicators (KPIs), and benchmarks to drive continuous improvement and ensure operational excellence.
Conduct regular audits and assessments to evaluate the effectiveness of the QMS and identify areas for enhancement.
Stay abreast of relevant regulations, guidelines, and standards governing animal research, including USDA, AAALAC, and IACUC requirements.

Develop and implement robust quality assurance programs to ensure the integrity and reliability of research data generated from animal studies.

Establish protocols for the validation and verification of testing methodologies, equipment, and facilities.
Oversee the documentation of standard operating procedures (SOPs), protocols, and other quality-related documents.

Collaborate with cross-functional teams, including researchers, veterinarians, facility managers, and regulatory affairs personnel, to address quality-related issues and drive continuous improvement.

Qualifications:
Bachelor's degree in biological sciences, veterinary medicine, or a related field preferred.

Minimum of 7-10 years of experience in quality management roles within animal testing facilities, preferably in the biotechnology or pharmaceutical industry.

In-depth knowledge of regulatory requirements and quality standards applicable to animal research, including USDA Animal Welfare Act, AAALAC accreditation, and IACUC guidelines.

Strong understanding of quality management principles, methodologies, and tools, Six Sigma, and Lean Manufacturing.
Excellent leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively across diverse teams.

Proven track record of driving quality initiatives, managing regulatory compliance, and implementing process improvements in a complex and regulated environment.

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