Pharma QA Leader: cGMP, Audits & Compliance

Perrigouk; New York (NY); Sur place; USD 90 000 - 140 000; Plein temps

Avantages offerts par ce poste

Competitive compensation

Forbes Best Employers by State 2024

Résumé du poste

Perrigo is seeking a QA Supervisor to lead a team ensuring quality oversight for bulk manufacturing, filling, and packaging of topical and suppository pharmaceutical products. You will ensure compliance with cGMP, FDA regulations, and internal quality systems, while supporting audits and inspections.

The role involves real-time quality support, documentation review, and continuous improvement initiatives. Schedule is Monday–Friday with potential weekend on-call.

Qualifications

• Bachelor's degree in a scientific discipline preferred; equivalent experience in a regulated manufacturing environment may be considered in lieu of a degree.
• Minimum of four (4) years of Quality Assurance experience in a regulated industry.
• Experience in pharmaceutical, biotechnology, medical device, cosmetics, or another FDA-regulated manufacturing environment is 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.

Responsabilités

• 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 requirements, FDA regulations, approved procedures, batch records, and internal quality standards.
• Review production, packaging, and quality documentation for accuracy, completeness, and compliance.
• Provide quality support to operations by addressing quality concerns, conducting risk assessments, and escalating issues when appropriate.
• Author, revise, review, and approve SOPs, Standard Work Instructions (SWIs), forms, and other controlled documents; develop new procedures and improve existing quality systems as needed.
• Lead or support investigations involving deviations, non-conformances, documentation errors, environmental monitoring excursions, and other quality events, ensuring timely implementation of corrective and preventive actions.
• Monitor compliance trends and identify opportunities for continuous improvement.
• Schedule and prioritize team activities and ensure personnel maintain required GMP qualifications and training.
• Support FDA inspections, customer audits, and internal audits while maintaining inspection readiness and assisting with remediation activities.
• Assist with quality metrics, management reviews, and other quality system initiatives.

Connaissances

Quality Assurance

cGMP knowledge

FDA regulations

SOP writing

Leadership

Documentation review

Formation

Bachelor's degree in scientific discipline

Outils

SAP

eQMS

Description du poste

Perrigo is seeking a QA Supervisor to lead a team ensuring quality oversight for bulk manufacturing, filling, and packaging of topical and suppository pharmaceutical products. You will ensure compliance with cGMP, FDA regulations, and internal quality systems, while supporting audits and inspections.

The role involves real-time quality support, documentation review, and continuous improvement initiatives. Schedule is Monday–Friday with potential weekend on-call.