Quality Systems Specialist
Tap Growth ai
Date: 8 hours ago
City: Cambridge, MA
Contract type: Full time
Remote
We're Hiring: Quality Systems Specialist!
We are seeking a detail-oriented and experienced Quality Systems Specialist to ensure our quality management systems meet regulatory standards and drive continuous improvement. The ideal candidate will have expertise in quality assurance processes, documentation management, and compliance requirements to maintain excellence across our operations.
Location: Cambridge, MA
What You'll Do
We are seeking a detail-oriented and experienced Quality Systems Specialist to ensure our quality management systems meet regulatory standards and drive continuous improvement. The ideal candidate will have expertise in quality assurance processes, documentation management, and compliance requirements to maintain excellence across our operations.
Location: Cambridge, MA
What You'll Do
- Serve as global process support for Deviation, CAPA, Change Control, Reg Intel, and Training processes
- Facilitate analysis of Quality Systems metrics and performance periodically
- Manage Quality Systems deviations and CAPAs, ensuring proper investigation, resolution, and preventive measures
- Oversee Regulatory Intelligence assessments and maintain associated documentation
- Facilitate the Change Control Review Board and maintain associated documentation
- Partner with SMEs and business reps to identify GxP training content needs and GxP curricula modification
- Support development of Quality-related training content
- Support quality systems audits and regulatory inspections
- Provide guidance and support to site quality teams in process implementation
- Bachelor's degree in Life Sciences, Engineering, or related field
- 2+ years of experience in Quality Systems within biotechnology or pharmaceutical industries
- 1+ years of experience in manufacturing, operations, or related business areas
- Demonstrated experience in process ownership and quality systems management
- Strong understanding of GMP, GLP, GCP regulations and ICH guidelines
- Experience with electronic quality management systems (Veeva)
- Strong process thinking and analytical skills
- Strong Excel experience
- Excellence in project management and organization
- Outstanding communication and presentation abilities
- Proven ability to influence without direct authority
- Strong facilitation and training skills
- Master's degree in related field
- ASQ certification (CQA, CQM)
- Experience with Lean Six Sigma methodologies
- International work experience
- Experience with change management and organizational development
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