Sr. Manager - Microbiology

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

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 Senior Quality Manager, 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.

What you'll be doing

• Develop a team of supervisors and/or department leads involved in microbiology testing of raw materials and finished good products.
• Supervise product testing procedures for bioburden, microbial identification, endotoxin, and solution particulate matter.
• Ensure compliance with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) and other relevant regulations and standards.
• Coordinate with cross-functional teams to address testing requirements and timelines in support of change controls, protocols, and engineering studies.
• Collaborate with Quality Assurance to achieve timely resolution of deviations, investigations, and corrective actions related to areas of responsibility.
• Participate in internal and external audits, including direct interfacing with regulatory agencies such as FDA.
• Remain informed about industry trends, regulatory changes, and emerging technologies related to microbiology testing.
• Develop, maintain, and establish action plans as needed for Key Performance Indicators (KPIs) and Metrics to maintain and improve the efficiency and effectiveness of product testing processes.
• Identify and lead continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
• Develops and ensures adherence to budget and reports on overspend as necessary to evaluate reason and possible corrections.
• Manages the coaching, training and development process of subordinates.
• Sustain a clean and safe work area using 6S principles.

What you'll bring

• Bachelor's degree in Science, concentration in Biology or Microbiology, preferred.
• Minimum 10 years professional experience in Quality, Manufacturing, Engineering or related field.
• Minimum 7 years confirmed experience in cGMP related industry.
• Minimum 5 years proven leadership/supervision and experience within an aseptic or sterile manufacturing site.
• Knowledge of microbiology testing techniques, including bioburden, endotoxin, solution particulate matter detection, and microbial identification.
• Familiarity with regulatory requirements including USP, FDA, and ISO standards.
• Demonstration of leadership, communication, and interpersonal skills.

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