Quality Supervisor

Perrigo Company plc; New York (NY); On-site; USD 72,000 - 88,000; Full time

Benefits offered by this job

Total Rewards

Forbes Best Employers by State 2024

Job summary

Perrigo Company plc in New York is seeking a QA Supervisor to lead a team of QA Inspectors responsible for in-process oversight of manufacturing and packaging of topical and related products. You will ensure compliance with cGMP, FDA regulations, and internal quality systems.

You will review documentation, support investigations and audits, develop and approve SOPs, lead corrective actions, and drive continuous improvement while coordinating training and GMP qualifications for the team.

Qualifications

• Bachelor's degree in a scientific discipline preferred; equivalent regulated experience may be considered.
• Minimum of four years of Quality Assurance experience in a regulated industry.
• Experience in pharmaceutical/biotech/medical device or other FDA-regulated environments.
• 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.
• Experience supporting FDA inspections and audits preferred.
• Strong written, verbal, organizational, and interpersonal skills.
• Knowledge of SAP and/or electronic quality management systems (eQMS) 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, 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.

Skills

Quality Assurance

cGMP Knowledge

Investigations

CAPA

SOPs

Leadership

Audits

Education

Bachelor's degree (scientific)

Tools

SAP

eQMS

Job description

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Join us on our One Perrigo journey as we evolve to win in self-care.

Description Overview

The QA Supervisor is responsible for leading a team of Quality Assurance Inspectors that provides quality oversight for bulk manufacturing, filling, and packaging operations involved in the production of topical and suppository pharmaceutical products. This role ensures compliance with current Good Manufacturing Practices (cGMP), FDA regulations, internal quality systems, and approved procedures.

The QA Supervisor serves as a key quality resource for Manufacturing, Packaging, Engineering, and Validation. Responsibilities include providing real-time quality support, maintaining quality systems, reviewing and approving quality documentation, supporting investigations, and assisting with audits and inspections to ensure product quality and regulatory compliance.

Schedule: First shift, Monday through Friday. Occasional weekend on-call support may be required.

Salary: $80,000

Scope of the Role

• 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.

Experience Required

• 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.
• Previous 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.
• Previous supervisory or leadership experience preferred.
• Experience supporting FDA inspections and audits preferred.
• Strong written, verbal, organizational, and interpersonal skills.
• Knowledge of SAP and/or electronic quality management systems (eQMS) preferred.

Benefits

We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

Find out more Total Rewards at Perrigo.

We are proud to be included in the Forbes list of "America’s Best Employers by State 2024". Find out more

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo