GMP Operational Quality Lead

Atrium; Boston (MA); On-site; USD 90,000 - 103,000; Full time

Job summary

Atrium is seeking an Operational Quality Manager to oversee QA for GMP manufacturing and testing, reviewing batch records, deviations, and environmental data to support product disposition.

The role requires leading investigations, change controls, and documentation reviews, with strong communication and prioritization skills in a fast-paced GMP environment. Onsite, M‑F, with hourly pay options.

Qualifications

• Bachelor’s degree in a scientific or allied health field with 5–7 years of relevant experience.
• Knowledge of current Good Manufacturing Practices (cGMP) in a pharmaceutical environment.
• Experience providing QA oversight for GMP manufacturing and testing operations.
• Experience reviewing GMP documentation from external vendors.
• Experience leading investigations, deviations, and change controls.
• Experience with systems such as Veeva, LIMS and Oracle.
• Strong attention to detail and effective written and verbal communication skills.
• Ability to manage competing priorities and timelines in a fast-paced environment.

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, including certificates of analysis and conformance, in accordance with procedures.
• Confirm all required documentation is complete and acceptable 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 proactively with internal and external partners and management.
• Maintain and archive records so documents are readily available and retrievable.
• 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

cGMP knowledge

Veeva

LIMS

Oracle

investigations

deviations

change controls

batch release

documentation review

clear communication

prioritization

Education

Bachelor's degree in science/health

Tools

Veeva

LIMS

Oracle

Job description

Atrium is seeking an Operational Quality Manager to oversee QA for GMP manufacturing and testing, reviewing batch records, deviations, and environmental data to support product disposition.

The role requires leading investigations, change controls, and documentation reviews, with strong communication and prioritization skills in a fast-paced GMP environment. Onsite, M‑F, with hourly pay options.