Associate Manager - Quality Systems and Compliance
Eau Claire, WI, US, 54703
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®, ACO®, 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 a blended-branded business to win in self-care.
Description Overview
We are seeking a detail-oriented and results-driven Associate Manager - Quality Systems and Compliance to join our team in the infant formula business. In this role, you will ensure that all quality systems, processes, and compliance measures meet industry regulations, company standards, and customer expectations. You will play a key role in monitoring, maintaining, and continuously improving quality systems while supporting compliance with regulatory requirements for infant formula products.
Scope of the Role
Quality Systems Management:
Develop, implement, and maintain quality management systems in alignment with regulatory requirements (e.g., FDA, Codex Alimentarius, EU standards) and ISO 22000.
Oversee document control, change management, and quality system audits.
Ensure proper handling of non-conformance reports and corrective/preventive actions.
Compliance Monitoring:
Monitor compliance with local, national, and international regulations for infant formula production.
Conduct internal audits and prepare for external inspections by regulatory agencies or customers.
Ensure the facility adheres to Good Manufacturing Practices (GMP) and Hazard Analysis and Critical Control Points (HACCP).
CAPA Program Oversight and Regulatory Compliance:
Manage the Corrective and Preventive Actions (CAPA) program to ensure effective resolution of quality and compliance issues, aligning with regulatory requirements such as FDA's 21 CFR Part 106 and 107 and Federal Food and Cosmetic Act (FD&C Act) for Quality Systems. Develop and maintain CAPA procedures, coordinate the implementation of corrective actions addressing root causes of non-conformances, and introduce preventive measures to mitigate risks. Oversee CAPA progress, ensuring timely documentation, closure of actions, and effectiveness verification through audits, data analysis, and performance metrics. Prepare comprehensive CAPA records and summaries for internal audits, external inspections, and regulatory submissions, supporting overall regulatory compliance and quality system excellence.
Consumer Complaint and Quality Management:
Oversee the end-to-end management of consumer complaints, including intake, documentation, investigation, and resolution, while ensuring accurate logging in the quality management system. Lead root cause analysis and collaborate with cross-functional teams to address issues effectively. Develop and implement corrective and preventive actions (CAPA) based on trends and findings, ensuring their timely execution and verification. Analyze complaint data to identify trends and recurring issues, providing actionable recommendations to senior leadership to drive quality and product improvements.
Experience Required
- Bachelor’s degree in Food Science, Microbiology, Chemistry, or a related field.
- Minimum of 5 years of experience in quality assurance/compliance, preferably in the infant formula or food manufacturing industry.
- Strong knowledge of regulatory requirements and standards (e.g., FDA, USDA, FSMA).
- Proficiency in quality systems such as CAPA, change control, and audit processes.
- Excellent communication and leadership skills with a strong ability to collaborate across teams.
- Certification in HACCP, SQF, or similar quality systems is a plus.
Skills & Competencies:
- Knowledge, experience, and skills with quality assurance functions. Strong involvement with industry professional associations is preferred. Network within the pharma industry and partner strategically with global regulators.
- Listening, negotiating and effective communication skills under pressure are highly preferred.
- Responsible for daily management of Quality Compliance and Quality Escalations. Develops and implements effective metrics and strategies
- Directs and manages QMS processes and reporting requirements.
- Quality Compliance, Quality Inspection and Audit, QMR, QA, QC, QRM
- Expertise in applying predictive analytics and big data/artificial intelligence to create predictive indicators
- Detail-oriented with a strong analytical mindset.
- Effective project management and organizational skills.
- Proactive approach to problem-solving and continuous improvement.
Supports Perrigo Quality Management Review Process
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 about 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 here
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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
Nearest Major Market: Eau Claire