GMP QA Lead: Operational Quality (12-Month Contract)

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 90,000 - 103,000; Full time

Job summary

Vertex Pharmaceuticals LLC in Boston, MA is seeking an Operational Quality Manager to provide QA oversight for GMP manufacturing and testing operations, reviewing batch records, deviations, in-process data, and product disposition decisions.

The role requires a Bachelor’s degree in a scientific field and 5–7 years of relevant experience, plus knowledge of cGMP and experience with Veeva, LIMS and Oracle to support investigations and change controls.

Qualifications

• Bachelor’s degree in a scientific or allied health field; 5–7 years of relevant experience or equivalent mix of education and experience.
• Knowledge of current Good Manufacturing Practices (cGMP) in a pharmaceutical environment.
• Experience providing QA oversight for GMP manufacturing and testing operations.

Responsibilities

• Review master batch records and approve quality tasks for manufactured products.
• Review in-process, environmental monitoring, and QC data including certificates of analysis and provide required quality approvals.
• Perform final review of executed batch records and critical systems documentation for conformance.
• Confirm all required documentation is complete before product or system release.
• Support investigations, deviations, and change controls within manufacturing operations.
• Support day-to-day management of the batch release process.
• Communicate with internal and external partners and management.
• Maintain and archive records for retrievability.
• Prepare metrics and data for program reporting.
• Escalate critical and major findings to Quality management.
• Collaborate with external vendors to review GMP documentation supporting product disposition.

Skills

QA oversight

GMP knowledge

cGMP compliance

Documentation review

Investigations

Change controls

Data analysis

Communication

Prioritization

Vendor collaboration

Education

Bachelor's degree in scientific or allied health field

Tools

Veeva

LIMS

Oracle

Job description

Vertex Pharmaceuticals LLC in Boston, MA is seeking an Operational Quality Manager to provide QA oversight for GMP manufacturing and testing operations, reviewing batch records, deviations, in-process data, and product disposition decisions.

The role requires a Bachelor’s degree in a scientific field and 5–7 years of relevant experience, plus knowledge of cGMP and experience with Veeva, LIMS and Oracle to support investigations and change controls.