Quality System Manager - Remote!

The Jackson Laboratory; United States; Remote; USD 85,987 - 130,000; Full time

Job summary

The Jackson Laboratory is looking for a qualified candidate to lead quality assurance efforts across all locations. The role involves developing and implementing strategies to enhance process efficiency, implementing risk mitigation, and overseeing audits. Candidates should have extensive experience in risk management and quality practices, supervising staff, and fostering a culture of quality improvement.

This hybrid position requires limited onsite presence initially, with flexibility thereafter. The salary range is competitive and will be commensurate with experience.

Qualifications

• Bachelor's degree and 7 years of relevant quality experience.
• Minimum of 2 years supervisory experience.
• Strong knowledge of Quality by Design (QbD) principles and stage-gate product development.

Responsibilities

• Develop a quality process development strategy.
• Proactively identify quality data trends and risks.
• Implement continuous quality improvements.

Skills

Risk management tools

Root Cause Analysis (RCA)

Statistical analysis

Quality metrics and performance monitoring

Change management

Interpersonal skills

Effective communication

Lean and continuous improvement

Education

Bachelor's degree

Tools

ISO 9001 standards

Design FMEA

Process FMEA (pFMEA)

Job description

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. This position will develop and execute JAX-wide strategies to enhance process efficiency, improve risk mitigation, and oversee key quality functions, including internal and external audits, deviation reviews, CAPA facilitation, document control, and change management. Position will be responsible for training and leading the Quality team in industry best practices, and will be responsible for reshaping quality culture across the global organization.

The salary range is $85.987 - $130,000. Salary will be determined based on qualifications and experience.

Hybrid Work Agreement

The hired candidate would need to be within driving distance to our Farmington, CT location (within 150 miles). The hired candidate work be 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.

Key Responsibilities (What you contribute)

• 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

Minimum Qualifications

• 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.
• 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.
• 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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About JAX

The Jackson Laboratory is an independent, nonprofit biomedical research institution with a National Cancer Institute-designated Cancer Center and nearly 3,000 employees in locations across the United States (Maine, Connecticut, California),Japan andChina. Its mission is to discover precise genomic solutions for disease and empower the global biomedical community in the shared quest to improve human health.

Founded in 1929, JAX applies over nine decades of expertise in genetics to increase understanding of human disease, advancing treatments and cures for cancer, neurological and immune disorders, diabetes, aging and heart disease. It models and interprets genomic complexity, integrates basic research with clinical application, educates current and future scientists, and provides critical data, tools and services to the global biomedical community. For more information, please visit www.jax.org.

EEO Statement

The Jackson Laboratory provides equal employment opportunities to all employees and applicants for employment in all job classifications without regard to race, color, religion, age, mental disability, physical disability, medical condition, gender, sexual orientation, genetic information, ancestry, marital status, national origin, veteran status, and other classifications protected by applicable state and local non-discrimination laws.