Quality Systems Specialist

The Specialist of Global Quality Systems will serve as the Process enabler and support for critical quality processes including Deviations, Corrective and Preventive Actions (CAPA), Change Control, Regulatory Intelligence, and Training within a global biotechnology environment. This role is essential in maintaining quality excellence and regulatory compliance across the enterprise while ensuring processes remain efficient and fit for purpose.

Key Responsibilities

• Process Support
• 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 subject matter experts and business representatives 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

Key Competencies

• Strong process thinking and analytical skills
• Strong experience in Excel
• Excellence in project management and organization
• Outstanding communication and presentation abilities
• Proven ability to influence without direct authority
• Strong facilitation and training skills

Can sit in any time zone PLEASE LIST LOCATION IN NOTES/SUMMARY

Requirements

Qualifications

• 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)

Preferred Qualifications

• 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

Benefits

• Fully Remote
• M-F 40 HOURS
• Start time 8 am EST