Quality Assurance Manager
The Jackson Laboratory
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $85,987 - $130,000 per year
About the role
- 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.
Requirements
- Bachelor's degree and 7 years of quality related experience.
- At least 2 years of supervisory experience.
- Lean/Six Sigma Certification preferred.
- Quality certifications (CQA, CQM/OE, etc.) a plus.
- Functional management/leadership experience in a pharmaceutical or biotechnology operation.
- Experience with and knowledge with ISO 9,001 standards.
- Expertise in supplier qualification and supplier quality management.
- Experience with CAPA processes, systems, root cause analysis and quality metrics.
- Skilled in audit execution and report writing.
- 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%.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assurancerisk managementcontinuous quality improvementsupplier quality managementCAPA processesroot cause analysisaudit executionreport writingISO 9001Lean/Six Sigma
Soft Skills
leadershipcoachinginterpersonal skillscommunication skillsrelationship buildingtrust buildingchange managementstrategic thinkingcollaborationproblem solving
Certifications
Lean/Six Sigma CertificationCQACQM/OE