Overview
ROLE AT A GLANCE:
Quality Assures Manager In this role, you will be responsible for managing quality activities across a portfolio of external manufacturing partners, ensuring products are manufactured in compliance with regulatory requirements and the highest quality standards, new product introduction (NPI), and validation.
HOW YOU’LL MAKE AN IMPACT:
- Leading quality oversight of external contract manufactures (CMs)
- Driving continuous quality improvement initiatives and remediation plans
- Managing quality performance monitoring, quality reviews, and supplier compliance
- Leading investigations, CAPAs, change controls, and quality risk assessments
- Supporting GMP audits, regulatory inspections, and quality compliance activities
- Reviewing and maintaining Quality Technical Agreements
- Collaborating closely with cross-functional stakeholders, including Operations, Regulatory Affairs, Science & Technology, and Commercial teams
- Acting as QA Lead during product technology transfers, validation activities, and new product introductions (NPI)
- Partner with Manufacturing, Sourcing R&D, Technical Centers, Regulatory, Marketing, Global Sourcing, and contract manufacturers to address quality related requirements throughout manufacturing of product.
- Provide technical support product risks, design considerations, quality expectations, and potential trade-offs to enable sound cross-functional decisions.
- Engage effectively with global stakeholders across cultures and time zones, fostering clear communication, accountability, and timely resolution of technical and operational challenges.
TEAM DYNAMICS:
- Drive alignment and consensus across functions on product design, risk management, quality, cost, and commercialization priorities, balancing business needs with technical and compliance requirements.
LEADERSHIP AND SUPERVISORY RESPONSIBILITIES:
- Will Supervise a staff of 5-10 direct and indirect reports
- Provides functional and project leadership by delivering Design Assurance guidance, driving risk resolution and consensus, and influencing cross-functional teams through development, commercialization, NPI, and validation activities.
QUALIFICATIONS FOR SUCCESS:
Education
- Bachelor’s degree in Dairy Science, Food Science, Pharmacy/B.Pharm, Chemical Engineering, or a closely related discipline. Master’s degree preferred.
Experience
- 10+ years of experience
- Proven experience managing HACCP systems and food safety programs.
- Experience leading audits and regulatory inspections.
- Demonstrated success driving compliance and continuous improvement initiatives.
- Working knowledge of FMEA, risk assessment, and HACCP.
- Understanding of quality management system (QMS) and regulatory requirements.
- Knowledge of food ingredients, nutrient function, product calculations, and data analysis.
- Ability to write concise technical documentation and communicate effectively with global, cross-cultural stakeholders.
Skills/Certifications
- Knowledge of applicable food and product regulations and policies, including labeling, process, and product relationships; familiarity with regulatory standards and requirements relevant to nutritional products, including infant formula where applicable.
- Significant experience within food manufacturing, regulated environments or quality leadership roles.
- Proven experience managing HACCP systems and food safety programmes.
- Experience leading audits and regulatory inspections.
- Demonstrated success driving compliance and continuous improvement initiatives.
- Working knowledge of FMEA, risk assessment, and HACCP.
- Understanding of quality management system (QMS) and regulatory requirements.
- Knowledge of food ingredients, nutrient function, product calculations, and data analysis.
- Ability to write concise technical documentation and communicate effectively with global, cross-cultural stakeholders.
- Significant experience within food manufacturing, regulated environments or quality leadership roles.
