Quality Supervisor

Scorpion Therapeutics; New York (NY); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive compensation

Benefits for you and your family

Career development opportunities

Job summary

Scorpion Therapeutics is seeking a QA Supervisor to lead a team of QA Inspectors ensuring cGMP compliance across bulk manufacturing, filling, and packaging of topical and related pharmaceutical products. You will review documentation, support investigations, and drive CAPA implementations.

The role requires 4+ years of QA experience in a regulated setting, strong knowledge of GMP standards, and hands-on ability to author and revise SOPs and controlled documents.

Qualifications

• Bachelor's degree in a scientific discipline required or equivalent regulated experience.
• 4+ years QA experience in a regulated industry.
• Pharmaceutical/biotech/medical device or other FDA-regulated manufacturing experience required.
• Knowledge of cGMP and quality systems.
• Experience reviewing documentation/investigations/deviations/CAPAs/change controls.
• Experience authoring/revising SOPs and controlled documents.

Responsibilities

• Supervise, coach, train, and evaluate QA Inspectors.
• Ensure manufacturing/packaging comply with cGMP, FDA regulations, approved procedures, batch records, and internal quality standards.
• Review production, packaging, and quality documentation for accuracy and compliance.
• Provide real-time quality support by addressing concerns, conducting risk assessments, and escalating issues.
• Author, revise, review, and approve SOPs, SWIs, forms, and other controlled documents; develop/improve quality systems.
• Lead/support investigations (deviations, non-conformances, documentation errors, environmental monitoring excursions) and ensure CAPA implementation.
• Monitor compliance trends and identify continuous improvement opportunities.
• Schedule/prioritize team activities; ensure GMP training/qualifications.
• Support FDA inspections, customer audits, and internal audits; assist with remediation.
• Support quality metrics, management reviews, and quality system initiatives.

Skills

Leadership/ Supervisory

Quality systems/cGMP

SOPs & documentation

Risk assessment & CAPA

Communication

Regulatory/audit support

SAP knowledge

Education

Bachelor's degree in a scientific discipline

Tools

SAP

eQMS

Job description

Description Overview

The QA Supervisor leads a team of Quality Assurance Inspectors providing quality oversight for bulk manufacturing, filling, and packaging operations for topical and suppository pharmaceutical products, ensuring compliance with cGMP, FDA regulations, internal quality systems, and approved procedures.

Scope of the Role

• Supervise, coach, train, and evaluate QA Inspectors.
• Ensure manufacturing/packaging comply with cGMP, FDA regulations, approved procedures, batch records, and internal quality standards.
• Review production, packaging, and quality documentation for accuracy, completeness, and compliance.
• Provide real-time quality support by addressing concerns, conducting risk assessments, and escalating issues.
• Author, revise, review, and approve SOPs, SWIs, forms, and other controlled documents; develop/improve quality systems.
• Lead/support investigations (deviations, non-conformances, documentation errors, environmental monitoring excursions) and ensure CAPA implementation.
• Monitor compliance trends and identify continuous improvement opportunities.
• Schedule/prioritize team activities; ensure GMP training/qualifications.
• Support FDA inspections, customer audits, and internal audits; assist with remediation.
• Support quality metrics, management reviews, and quality system initiatives.

Experience Required

• Bachelor's degree in a scientific discipline preferred; equivalent regulated experience may substitute.
• 4+ years QA experience in a regulated industry.
• Pharmaceutical/biotech/medical device/cosmetics or other FDA-regulated manufacturing experience required.
• Knowledge of cGMP and quality systems.
• Experience reviewing documentation/investigations/deviations/CAPAs/change controls.
• Experience authoring/revising SOPs and controlled documents.
• Supervisory/leadership experience preferred; FDA inspection/audit support preferred.
• Strong written, verbal, organizational, interpersonal skills.
• SAP and/or eQMS knowledge preferred.

Schedule

First shift, Monday–Friday; occasional weekend on-call support may be required.

Benefits

Competitive compensation; benefits for you and your family; career development opportunities.