Position: Quality Systems Specialist

Location: Cambridge, MA (Hybrid preferred)

Type: Temp to Hire (Not available for C2C)

M-F 40 HOURS

Overview:

Support key quality processes (Deviation, CAPA, Change Control, Regulatory Intelligence, and Training) in a global biotech environment, ensuring compliance and efficiency.

Responsibilities:

• Support global quality processes (Deviation, CAPA, Change Control, Reg Intel, Training).
• Analyze quality metrics and performance.
• Manage deviations and CAPAs.
• Oversee Regulatory Intelligence and Change Control documentation.
• Develop GxP training content and support audits/inspections.
• Guide site quality teams in process implementation.

Required Qualifications:

• Bachelor's degree in Life Sciences, Engineering, or related field.
• 2+ years of experience in Quality Systems in biotech/pharma.
• Process ownership and quality systems management experience.
• Technical writing, SOPs
• Strong understanding of GMP, GLP, GCP regulations, and ICH guidelines.
• Experience with electronic quality management systems (Veeva).

Preferred Qualifications:

• Master's degree in a related field.
• ASQ certification (CQA, CQM).
• Lean Six Sigma experience.
• International work experience.
• Change management and organizational development experience.