QA Supervisor: GMP & FDA Quality Lead

Biopharma Careers; Bronx (ID); On-site; USD 68,000 - 92,000; Full time

Benefits offered by this job

Total Rewards program

Forbes Best Employers list 2024

Job summary

Perrigo is seeking a QA Supervisor to lead a team ensuring quality oversight across manufacturing and packaging of pharmaceutical products. The role requires a strong background in cGMP, FDA regulations, and documentation control, with hands-on QA leadership experience.

The position focuses on real-time quality support, investigations, and ensuring readiness for audits while driving continuous improvement and training to maintain GMP qualifications.

Qualifications

• Bachelor's degree in a scientific discipline preferred or equivalent experience in a regulated manufacturing environment.
• Minimum of four (4) years of Quality Assurance experience in a regulated industry.
• Experience in pharmaceutical/biotech/medical device or FDA-regulated manufacturing environments required.
• Demonstrated knowledge of cGMP requirements and quality systems.
• Experience reviewing manufacturing and packaging documentation, investigations, deviations, CAPAs, and change controls.
• Experience authoring and revising SOPs and other controlled documents.
• Previous supervisory or leadership experience preferred.
• Strong written, verbal, organizational, and interpersonal skills.
• Knowledge of SAP and/or eQMS is preferred.

Responsibilities

• Supervise, coach, train, and evaluate QA Inspectors responsible for in-process oversight of manufacturing and packaging operations.
• Ensure manufacturing and packaging activities comply with cGMP, FDA regulations, procedures, batch records, and internal quality standards.
• Review production, packaging, and quality documentation for accuracy and compliance.
• Provide quality support to operations by addressing quality concerns and conducting risk assessments.
• Author, revise, review, and approve SOPs and related documents; develop new procedures and improve quality systems.
• Lead investigations involving deviations, non-conformances, and CAPAs; ensure timely corrective actions.
• Monitor quality metrics and drive continuous improvement opportunities.
• Support FDA inspections, audits, and remediation activities.

Skills

Quality Assurance

Supervisory experience

cGMP knowledge

FDA inspections knowledge

SOP writing

Communication skills

Education

Bachelor's degree in science

Tools

SAP

eQMS

Job description

Perrigo is seeking a QA Supervisor to lead a team ensuring quality oversight across manufacturing and packaging of pharmaceutical products. The role requires a strong background in cGMP, FDA regulations, and documentation control, with hands-on QA leadership experience.

The position focuses on real-time quality support, investigations, and ensuring readiness for audits while driving continuous improvement and training to maintain GMP qualifications.