Quality System Manager - Remote
$178,838–$178,838 year
RemoteCalifornia, United States or Connecticut, United States
Job Summary
Develop long-term process development and improvement strategies to harmonize quality practices across all JAX domestic and international locations. Proactively analyze quality data to identify trends and risks, then implement risk mitigation strategies and continuous quality improvements in systems. Lead the Quality team by coaching, counseling, and directing personnel while ensuring high-quality policies are propagated organization-wide. Co-lead implementation of quality and regulatory compliance software systems and manage key functions including audits, deviation reviews, CAPA facilitation, and change management. This role requires a Bachelor's degree, seven years of relevant quality experience, and supervisory expertise in risk management tools and ISO standards. The position is remote with occasional travel to JAX locations, offering a salary range of $85,987 to $130,000.
Required Qualifications
- Bachelor's degree
- 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
- Functional management/leadership experience in a pharmaceutical or biotechnology operation
- 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%
- The ideal candidates will be located on the east coast
Desired Qualifications
- Lean/Six Sigma Certification preferred
- Quality certifications (CQA, CQM/OE, etc.) a plus
- Research regulatory compliance experience preferred
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.