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.
This role is remote with occasional travel to JAX locations. The ideal candidates will be located on the east coast.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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