Senior Quality Manager

Zvh; Arkansas; Sur place; USD 136 000 - 170 000; Plein temps

Avantages offerts par ce poste

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Paid time off and holidays

Résumé du poste

Baxter is seeking a senior Quality Leader in Arkansas to manage the Chemistry and Microbiology laboratories, driving conformance to quality policies and regulatory standards. You will lead a team, implement quality systems, and coordinate with regulators to ensure product integrity.

Responsibilities include overseeing daily lab operations, driving continuous improvement, and ensuring timely product releases while maintaining cGMP compliance across functions.

Qualifications

• Strong knowledge of cGMP, FDA, USP standards.
• Proven leadership and project management skills.
• Excellent analytical and problem-solving abilities.
• Ability to supervise a team and communicate effectively.
• Understanding of environmental monitoring and contamination control.

Responsabilités

• Manage activities of chemistry laboratory and process validation with responsibility for results in terms of product quality and conformance to policies.
• Ensure compliance with quality systems and regulatory requirements in the labs.
• Coordinate with regulators during inspections and audits.
• Oversee microbiology lab activities and related safety and quality results.
• Lead continuous improvement projects to enhance quality, reliability, and cost efficiency.
• Manage department workflow and staff development; monitor budgets and resources.

Connaissances

Analytical thinking

Leadership

Regulatory knowledge

Quality systems

Communication

Formation

Bachelor's degree in Science with biology/microbiology focus

Description du poste

Company Overview

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.

Position Summary

Manage through subordinates the coordination of the activities both the Chemistry and Microbiology Laboratory. Responsible for results in terms of product quality and conformance to regulations and Baxter quality policies.

Job Responsibilities

• Manage the activities of the chemistry laboratory and process validation with responsibility for results in terms of product quality, performance and safety.
• Implements the quality systems procedures and manages compliance in a section or department.
• Understands and assures conformance to regulations in the Chemistry/Microbiology laboratory.
• Manage the activities of the microbiology laboratory with responsibility for results in terms of product quality, performance, and safety.
• Implements the quality systems procedures and manages compliance in a section or department.
• Interfaces with regulators during regulatory inspections.
• May participate in or manage quality assessments of internal operations and suppliers 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.
• Coordinate and communicate with Lab Services and QA as required to maintain departmental operations.
• Advises on technical procedures, techniques, and equipment, and maintains conformance with specific operational standards.
• Maintains quality checks on the safety of laboratories and insures maintenance of the facilities according to good laboratory practices.
• Reviews testing and laboratory records for accuracy and compliance with cGMP and company policies and procedures.
• Maintains laboratory supplies inventory by checking stock to determine inventory level; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies and approval of corresponding invoice.
• Oversees daily workflow of the department or direct reports.
• Develop and support career paths and professional growth opportunities for Quality Control staff that will provide continuous improvement in product quality and operations.
• Manage department to ensure timely release of products to meet company and customer quality requirements and timelines Following up on non-conformances, investigating corrective actions, and implementing appropriate corrective & preventative actions plans.
• Develops budget for the department and ensures adherence to the budget.
• Manages the coaching, training and development process of subordinates.
• Sustain a clean and safe work area using 6S principles Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP).

Knowledge, Skill and Abilities

• Thorough knowledge of applicable procedures, specifications, regulations and standards.
• Strong analytical and problem solving skills.
• Ability to manage/supervise a team of employees.
• Good communication and leadership skills.
• Good interpersonal/communication/influencing/negotiation skills.
• Good project management skills.
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
• Strong technical written skills.

Education & Experience Requirements

• Bachelor's degree in Science, with a concentration in Biology, Microbiology, or a related field preferred.
• Minimum 10 years of professional experience in Quality, Manufacturing, Engineering, or a related field.
• Minimum 7 years of experience in a cGMP-regulated industry.
• Experience with environmental monitoring and contamination control programs in a regulated manufacturing environment.
• 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.
• Demonstrated leadership, communication, and interpersonal skills.
• Strong analytical and problem‑solving abilities.

Compensation

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 - $170,000 annually.

We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors.

Join us and enjoy the competitive compensation and benefits we offer to our employees.

Benefits

• 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.

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, let us know the nature of your request along with your contact information.

Company Culture

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.