Biologics GMP Quality Senior Manager (1-Year Contract)

BioPharma Consulting JAD Group; Boston (MA); On-site; USD 150,000 - 220,000; Full time

Benefits offered by this job

1 year contract with possible extend

Administrative shift

Job summary

BioPharma Consulting JAD Group seeks a GMP Operational Quality Senior Manager to lead QA/quality assurance for drug substances, drug products and devices. You will coordinate complex projects, resolve issues with CMOs and suppliers, and oversee investigations, CAPA and risk management programs.

The role requires deep cGMP expertise in biologics and devices, extensive experience with change control, audits and document systems (QDocs, TrackWise, Veeva).

Qualifications

• 8 years of experience in QA GMP in biologics and devices.
• Experience with contract manufacturers and continuous improvement.
• Experience with quality risk management best practices.
• Experience leading investigations, RCA and CAPA.
• Experience with electronic document management systems.

Responsibilities

• Collaborate with partners to resolve complex quality issues.
• Participate in cross-functional teams as QA resource.
• Draft and enforce Quality Agreements with CMOs/Suppliers.
• Assist Change Control owners and assess changes.
• Lead investigations, CAPA, and root cause analyses.
• Review master and executed batch records for DS/DP/FG disposition.
• Support internal and external audits.
• Identify risks and mitigation plans.

Skills

cGMP knowledge

GMP compliance

CAPA management

RCA

Quality risk mgmt

QMS tools

Document control

Vendor management

Education

Bachelor's degree in science

Tools

QDocs

TrackWise

Veeva

Job description

BioPharma Consulting JAD Group seeks a GMP Operational Quality Senior Manager to lead QA/quality assurance for drug substances, drug products and devices. You will coordinate complex projects, resolve issues with CMOs and suppliers, and oversee investigations, CAPA and risk management programs.

The role requires deep cGMP expertise in biologics and devices, extensive experience with change control, audits and document systems (QDocs, TrackWise, Veeva).