Quality System Manager

This is a fully remote position, open to applicants in Connecticut.

📋 Description

• Lead initiatives to unify quality practices across all JAX locations, both domestically and internationally when applicable.

• Create and implement strategies across JAX to enhance process efficiency and strengthen risk management.

• Supervise internal and external audits, manage deviation reviews, facilitate CAPA, oversee document control, and handle change management.

• Educate and guide the Quality team in industry best practices.

• Transform the quality culture throughout the global organization.

• Collaborate with the global organization to establish a long-term strategy for process development and enhancement.

• Identify, evaluate, and utilize quality data to spot trends and risks.

• Conduct risk-based assessments and support strategies for risk mitigation.

• Implement ongoing quality improvements to minimize complexity and enhance effectiveness, efficiency, productivity, sustainability, and globalization.

• Formulate and enforce organization-wide policies for quality process development and improvement.

• Provide strategic leadership in setting policies.

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

• Co-lead the rollout of quality and regulatory compliance software systems.

• Guide quality personnel through coaching, counseling, and leadership development.

• Maintain up-to-date professional and technical knowledge.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor's degree with 7 years of pertinent quality experience.

• At least 2 years of supervisory experience.

• Proficient in risk management tools, such as Design FMEA and Process FMEA (pFMEA).

• Skilled in Root Cause Analysis (RCA), statistical analysis, and data-driven decision-making.

• Familiarity with MSA/Gauge R&R, quality metrics, and performance monitoring.

• Knowledgeable about ISO 9001 standards.

• Understanding of Computer System Validation requirements.

• Strong grasp of Quality by Design (QbD) principles and stage-gate product development.

• Experience in functional management/leadership within a pharmaceutical or biotechnology setting.

• Background in change management within a multi-site, complex environment.

• Advanced interpersonal skills for building intricate relationships across cultures, disciplines, and organizational levels.

• Excellent verbal and written communication skills for interactions with senior leaders.

• Ability to devise, analyze, and assess complex plans and programs.

• Capacity to stay informed on industry practices, regulatory requirements, and changes.

• Willingness to travel 10% of the time.

• Lean/Six Sigma certification is preferred.

• Quality certifications such as CQA or CQM/OE are advantageous.

• Prior experience in research regulatory compliance is preferred.

🏝️ Benefits

• Flexible remote work arrangement.

• Opportunities for professional growth through educational workshops, professional publications, personal networking, and membership in professional societies.

• Commitment to equal employment opportunities.