Quality System Manager - Farmington, CT - Hybrid

About the role

This position will direct efforts to harmonize practices across all JAX locations, both domestic and international where applicable, drive organizational change and implement quality improvements.

Responsibilities

• 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
• Determine and implement the quality assurance/quality system subset strategy for global team
• 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

Requirements

• Bachelor's degree and 7 years of relevant quality experience
• Minimum of 2 years supervisory experience
• Expertise in risk management tools including Design FMEA, Process FMEA (pFMEA)
• Proficiency in Root Cause Analysis (RCA), statistical analysis and data-driven decision-making
• Experience with MSA/Gauge R&R, quality metrics and performance monitoring
• Experience with and knowledge of ISO 9,001 standards
• Computer System Validation requirements
• Strong knowledge of Quality by Design (QbD) principles and stage-gate product development
• Licenses/Certifications: Lean/Six Sigma Certification preferred. Quality certifications (CQA, CQM/OE, etc.) a plus
• Functional management/leadership experience in a pharmaceutical or biotechnology operation
• Research regulatory compliance experience preferred

Qualifications

• 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%

Skills

• Knowledge of Quality by Design (QbD) principles and stage-gate product development
• Experience with and knowledge of ISO 9,001 standards
• Experience with MSA/Gauge R&R, quality metrics and performance monitoring
• Experience with risk management tools including Design FMEA, Process FMEA (pFMEA)
• Experience with Root Cause Analysis (RCA)
• Experience with Lean/Six Sigma

Benefits

The Jackson Laboratory is committed to providing a comprehensive benefits package that includes:

• Health insurance
• Retirement savings plan
• Flexible spending accounts
• Employee assistance program
• Telemedicine services

Pay

The salary range for this position is $85,987 - $130,000. Salary will be determined based on qualifications and experience.

Schedule

The Jackson Laboratory offers a hybrid work agreement. The hired candidate would need to be within driving distance to our Farmington, CT location (within 150 miles). The hired candidate will work onsite for the first 2 weeks to learn about the organization, then 1 day per week for 2 months and 1 day per week thereafter. The hired candidate would need to be available to come onsite in the event of emergencies requiring support.