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Cancer. Diabetes. Alzheimer’s. Heart disease. JAX leads the search to cure diseases rooted in our DNA.
Quality Assurance Manager
Location
United States
Posted
39 days ago
Salary
$86.0K - $130K / year
Seniority
Lead
Job Description
Quality Assurance Manager
The Jackson Laboratory
• Develop a long-term process development and improvement strategy, focused on assuring quality, and in collaboration with others in the global organization. • Proactively identify, analyze and leverage quality data to identify trends and risks, manage risk-based assessments and support the implementation of risk mitigation strategies. • Develop and implement continuous quality improvements in systems to reduce complexity, improve effectiveness, efficiencies and productivity and ensure sustainability and globalization. • Develop and ensure a high-quality process development and improvement policy is propagated, understood, and implemented organization-wide; provide strategic leadership in a policy setting. • Determine and implement the quality assurance/quality system subset strategy for global team. • Co-lead the implementation of quality and regulatory compliance software systems. • Direct quality personnel by coaching, counseling, and leading employees. • Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies. • Other duties as assigned.
Job Requirements
- Bachelor's degree and 7 years of quality related experience.
- At least 2 years of supervisory experience.
- Lean/Six Sigma Certification preferred.
- Quality certifications (CQA, CQM/OE, etc.) a plus.
- Functional management/leadership experience in a pharmaceutical or biotechnology operation.
- Experience with and knowledge with ISO 9,001 standards.
- Expertise in supplier qualification and supplier quality management.
- Experience with CAPA processes, systems, root cause analysis and quality metrics.
- Skilled in audit execution and report writing.
- Research regulatory compliance experience preferred.
- Grows relationships with key organizational influencers and customers by building credibility and trust.
- Experience with change management in multi-site, complex environment.
- Advanced interpersonal skills sufficient for developing complex, dynamic relationships with a diverse variety of individuals representing a broad cross-section of cultures, disciplines, and levels of sophistication.
- Advanced verbal and written skills sufficient to communicate with the senior leaders in a variety of partner institutions.
- Ability to formulate, analyze and evaluate complex plans and programs.
- Ability to keep current on industry practices, regulatory requirements and industry changes.
- Champion of Lean and continuous improvement.
- Ability to travel, 10%.
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