Manager – Contract Quality Assurance

Overview

ROLE AT A GLANCE:

Quality Assurance 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)

TEAM DYNAMICS:•    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.•    Drive alignment and consensus across functions on product design, risk management, quality, cost, and commercialization priorities, balancing business needs with technical and compliance requirements.

Qualifications

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.