Sr. Manager - Microbiology

Baxter International Inc.; Marion (NC); On-site; USD 136,000 - 187,000; Full time

Benefits offered by this job

Medical and dental coverage from day 1

401(k) with company matching

Employee Stock Purchase Plan (ESPP)

Paid holidays and PTO

Job summary

Baxter International Inc. in the United States is seeking a Senior Quality Manager to lead a team responsible for microbiology testing and quality assurance across raw materials and finished products.

This role focuses on ensuring GMP/GLP compliance, driving continuous improvement, and guiding cross-functional collaboration to meet regulatory requirements. The position requires extensive leadership experience in a cGMP environment, familiarity with USP/FDA/ISO standards, and a commitment to

Qualifications

• Bachelor's degree in Science, biology or microbiology preferred.
• Minimum 10 years in Quality, Manufacturing, Engineering or related field.
• Minimum 7 years in a cGMP-related industry.
• Minimum 5 years of leadership/supervision in aseptic/sterile manufacturing sites.
• Knowledge of microbiology testing techniques and regulatory standards (USP, FDA, ISO).

Responsibilities

• Develop a team of supervisors and department leads for microbiology testing of materials and products.
• Supervise bioburden, endotoxin, and particulate matter testing procedures.
• Ensure GMP/GLP compliance and other relevant standards.
• Coordinate with cross-functional teams on testing requirements and change controls.
• Collaborate with QA to resolve deviations, investigations, and CAPAs.

Skills

Leadership

Communication

Interpersonal skills

Analytical thinking

Problem solving

Education

Bachelor's degree in Science (Biology or Microbiology)

Job description

This is whereyour 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.
• Strong analytical and problem-solving skills.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $136,000 - $187,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses and long-term incentives.

Please note this job description is not crafted to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as needed.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.