Quality Operations Manager Hickory, NC

Job Description

Quality Operations Manager I job kory, NC.

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

Your Role at Baxter

This is where your creativity addresses challenges

You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Quality Operations Manager I, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in.

You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

• Manage the activities of a section or department in the Quality Assurance organization with responsibility for results in terms of compliance, product quality, performance and safety
• Implement the quality systems procedures and manages compliance in the production operations such as formulation, filling and packaging of IV solutions in flexible containers
• Understands and assures conformance to FDA (CBER and CDER), TUV and other regulations for drug manufacturing. Interfaces with regulators during regulatory inspections
• May participate in internal assessments of internal operations to analyze compliance and assess risk
• Interacts frequently with subordinate supervisors and functional peer group managers
• Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements
• Develops budget for a section or department and ensures adherence to the budget
• Manages the coaching, training and development of subordinates

• BS in science or engineering
• 5+ years experience in Quality, Manufacturing, Engineering or related field which should include 1-2 years of supervisory experience
• Thorough knowledge of drug regulations and standards
• Strong analytical, critical thinking and problem-solving skills
• Ability to manage, develop and supervise a…