GMP Quality Lead (12-Month Contract, Possible Extension)

Hw3 Llc; Boston (MA); On-site; USD 56,000 - 95,000; Full time

Job summary

Hw3 Llc in Boston, MA is seeking an experienced QA professional to lead quality activities in a GMP pharmaceutical/biotech setting on a 12-month contract, with extension possible up to 3 years. Up to $69 per hour (W2).

The role covers deviations, CAPA, change control, batch release support, and ensuring GMP compliance across manufacturing, QA and validation teams. Strong communication and regulatory knowledge required (FDA/EMA).

Qualifications

• 5+ years in GMP pharma/biotech QA environment.
• Strong experience with deviations, CAPA, and change control.
• Experience supporting manufacturing or commercial operations.
• Solid knowledge of GMP, FDA/EMA regulations, and quality systems.
• Excellent communication and stakeholder management skills.

Responsibilities

• Lead and support quality activities including deviations, CAPAs, change controls and investigations.
• Review and approve GMP documentation, procedures and quality records.
• Support batch release, product quality and manufacturing activities.
• Collaborate with Manufacturing, Engineering, Validation and QA to ensure GMP compliance.
• Provide guidance on quality standards, processes and regulatory requirements.
• Support continuous improvement and timely resolution of quality issues.

Skills

GMP knowledge

QA experience

Deviations handling

CAPA management

Change control

Regulatory compliance

Stakeholder management

Job description

Hw3 Llc in Boston, MA is seeking an experienced QA professional to lead quality activities in a GMP pharmaceutical/biotech setting on a 12-month contract, with extension possible up to 3 years. Up to $69 per hour (W2).

The role covers deviations, CAPA, change control, batch release support, and ensuring GMP compliance across manufacturing, QA and validation teams. Strong communication and regulatory knowledge required (FDA/EMA).