Quality Assurance Regional Manager

Benefits:

• 401(k)
• Flexible schedule
• Health insurance

Quality Assurance Regional Manager
Defiance, Ohio
Full Time (Onsite)

Summary:
The Quality Assurance Regional Manager-Midwest is a key member of the corporate quality leadership team and will be based at our Defiance, OH or Bridgeton, MO site, responsible for ensuring that products manufactured across multiple sites are safe, compliant with Balchem, customer, and regulatory standards, and meet quality expectations. This role drives a culture of excellence through leadership, coaching, and cross-functional collaboration.

(1) People:
- Responsible for development and performance of the regional quality team
- Builds strong cross functional relationships and demonstrates ability to effectively influence sites strategy
- Develops a culture that drives quality improvements and efficiently interfaces with operational excellence processes
- Develop and deliver training programs focused on food safety and quality
- 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
(2) Systems:
- Accountable for the effective application of Product Safety, Product Quality and prerequisite systems regionally. 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.
- Accountable for an effective 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
- Interface with operational excellence programs to maximize effectiveness
- Provide support and aid in preparation for customer visits and external audit
- Share best practices and integrate quality systems across sites.
(3) 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

REQUIREMENTS:
- Bachelor’s degree in Science or related field.
- 10+ years of experience in food, supplement, or related industry, including management.
- Familiarity with FDA, HACCP, SQF, and industry best practices.
- Ability to lift 50 lbs; required to stand, walk, sit, and reach.

Skills and Certifications:
- 10 years+ Quality Assurance experience
- Solid FDA, HACCP, SQF, and industry best practices experience
- Bachelors Degree
- US citizen or permanent resident
- Industry experience-Food/Bev Mfg, Pharma, Medical Device
- Strong Supervisory/ mentorship of teams