QA Manager - CAPA

Requirements:

• 5 years+ Quality Assurance experience
• Solid FDA, HACCP, SQF, and industry best practices experience
• Bachelor’s Degree
• Creates and maintains a Quality culture
• Industry experience-Food/Bev Mfg, Pharma, Medical Device

Key Responsibilities:

Maintaining customer quality satisfaction through the implementation and use of programs to control raw materials, in-process materials, production process, environmental conditions and finished products.
Empowers and develops their team and cross functional teams. Performs evaluations and creates development and or training plans for team members and manages employee relations.
Ensures compliance with applicable laws and regulations such as FDA, EPA, OSHA and other state and federal agencies. Ensures compliance with contracted third-party certifications such as GFSI, Kosher, Halal, RSPO or others as needed.
Conducts or coordinates Customer, Vendor and/or third-party audits and regulatory inspections. Executes plans that drive operational excellence for the operation. Prepares and oversees customer site visits and audits.
Interacts with other Quality Managers, and corporate leadership and ensures timely issue escalation. Leads 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.
Manages 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.

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
Provide support and aid in preparation for customer visits and external audits

Knowledge & Experience:

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
5+ years of functional leadership experience