Quality Assurance Manager

About the role

The Quality Assurance Manager is a key member of the manufacturing site leadership team responsible for developing, implementing, and administering quality assurance and quality control functions to ensure safety integrity and conformance with regulatory, corporate, site, and customer requirements.

Responsibilities

• Maintain customer quality satisfaction through the implementation and use of programs to control raw materials, in-process materials, production process, environmental conditions and finished products.
• Empower and develop the team and cross-functional teams.
• Perform evaluations and create development and/or training plans for team members and manage employee relations.
• Ensure compliance with applicable laws and regulations such as FDA, EPA, OSHA and other state and federal agencies.
• Ensure compliance with contracted third party certifications such as GFSI, Kosher, Halal, RSPO or others as needed.
• Conduct or coordinate Customer, Vendor and/or third party audits and regulatory inspections.
• Execute plans that drive operational excellence for the operation.
• Prepare and oversee customer site visits and audits.
• Interact with other Quality Managers, and corporate leadership and ensure timely issue escalation.
• Lead quality team in commercial product onboarding and trial reviews, specification creation, formula and label reviews, inspection plans for raw materials, in process materials and finished materials.
• Manage departmental staffing, management commitment and review process, budget & expenses and capital projects.

Secondary Responsibilities

• Partnership with site leaders and cross-functional partners for goal setting, decision-making alignment, and training and development needs.
• Supports Supply Chain, Learning and Development, and Commercialization functions as needed.
• People Responsible for development and performance of the site quality team and ensuring training programs are in place for cross-functional teams.
• Builds strong cross-functional relationships and demonstrates ability to effectively influence and execute site strategy.
• Develops a culture that drives quality improvements and efficiently interfaces with operational excellence processes.
• Communicate effectively with internal and external customers.
• Timely escalation and communication of food safety, quality, financial issues.
• Effectively cascade goals using tools such as SMART goals. Aligns with teams on standard work.
• Motivates and builds team strength.
• Makes determinations and decisions on performance and pay for team members.

Systems

• Responsible for the effective application of site Product Safety, Product Quality and prerequisite systems.
• Ensures these systems effectively interface with change control and commercialization processes.
• Strong ability to root cause issues and eliminate the cause or implement engineering or systems improvements to enact robust prevention.
• Applies use of basic root cause tools.
• Responsible for execution of internal audit program and ensures systems are working to reduce risk, and that corrective actions are completed.
• Drives priorities that have largest positive impact on key performance indicators and metrics including but not limited to; Inspection/Compliance performance, First Pass Quality, Complaints, Disposals, Inventory Health, Customer Responsiveness, CAPA closure and effectiveness, systems performance, environmental & sanitation performance.
• Ensures that response to customers, inspectors and auditors are professional, timely, and in scope.
• Collaborates with R&D, Production, and commercial teams in the development and preparation for production of new Products, Processes, and Equipment to support new product/customer launches.
• Ensures the process quantifies the probability of success and clearly communicates the risks and proposed mitigations as an outcome of first-time makes.
• Interfaces with operational excellence programs to maximize effectiveness.
• Provides support and aid in preparation for customer visits and external audits.

Qualifications

• Operated in an FDA regulated environment, ideally food or dietary supplement.
• Assess and mitigate food safety, regulatory, and cost risks.
• Apply sanitation principles effectively.
• Application of Statistical Process Control (SPC) for process evaluation and improvements.
• Effective project manager that knows how to prioritize and meet deadlines.
• 4+ years of functional leadership experience.

Requirements

• Bachelor's degree.
• Project Management & Change Management Experience.
• 4+ years of experience in food, supplement, or related industry.
• GFSI Scheme (ie SQF, BRC) Certification focused on Quality and Food Safety for Supply Chain requirement: PCQI or HACCP.
• Solid FDA, HACCP, SQF, and industry best practices experience.
• Creates and maintains a Quality culture.
• US citizen or permanent resident.