Manager, QMS

Baxter International Inc.•Round Lake, IL

1d•$112,000 - $154,000

About The Position

As the Quality Management System (QMS) Program Leader at Baxter, you will oversee a portfolio of quality system programs that support product quality, regulatory compliance, and operational excellence. You will serve as the site leader for investigation management and provide governance and strategic direction for customer complaints, change control, APQR, and management review processes. This visible leadership role establishes quality governance, strengthens accountability, develops high-performing teams, and ensures risks are proactively identified, evaluated, and addressed. Success is measured through improved process performance, inspection readiness, data-driven decisions, and effective quality systems that support patients, customers, and business objectives.

Requirements

Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, Regulatory Affairs, or a related technical discipline.
At least 8 years of progressive experience in Quality, regulated manufacturing, compliance, laboratory operations, engineering, product surveillance, or similar environments within pharmaceutical, biotechnology, medical device, or other highly regulated industries.
At least 3 years of leadership experience managing people, leading quality programs, or directing significant cross-functional quality initiatives.
Demonstrated expertise in cGMP regulations, quality system governance, investigations, CAPA, customer complaints, change control, quality risk management, and data integrity principles.
Ability to analyze complex quality data, identify trends, assess risk, and translate insights into business decisions and continuous improvement actions.
Experience leading regulatory inspection readiness activities and presenting quality performance, risks, and recommendations to senior leadership.

Nice To Haves

Advanced degree in a scientific, engineering, quality, or related discipline.
Experience leading multiple Quality Management System programs within pharmaceutical, biotechnology, or medical device manufacturing environments.
Experience with FDA, Health Canada, or other global regulatory authority inspections and responses.
Proficiency with electronic Quality Management Systems (eQMS), such as TrackWise, and analytics tools including Power BI, Tableau, Smartsheet, or advanced Excel reporting.
ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Six Sigma Black Belt, RAC, or comparable professional certification.

Responsibilities

Lead the site Quality Management System portfolio, overseeing investigations, customer complaints, change control, APQR, management review, and related quality programs.
Establish governance frameworks, performance measures, escalation processes, and risk-based priorities to strengthen compliance and operational effectiveness.
Analyze quality data and trends to identify emerging risks, recurring issues, systemic opportunities, and preventive actions.
Partner with Manufacturing, Engineering, Quality Control, Regulatory Affairs, Validation, Supplier Quality, and other cross-functional teams to support timely, evidence-based decisions and sustainable solutions.
Develop and coach Quality professionals, fostering accountability, capability growth, and continuous improvement.
Monitor quality performance through integrated scorecards and reporting, using metrics to improve process health, effectiveness, and organizational outcomes.
Represent quality system programs during internal audits, customer assessments, and regulatory inspections, while maintaining ongoing inspection readiness.

Benefits

Medical and dental coverage starting on day one.
Basic life, accident, short-term and long-term disability, and business travel accident insurance.
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount.
401(k) Retirement Savings Plan with employee contributions and company matching.
Flexible Spending Accounts.
Educational assistance programs.
Paid holidays.
Paid time off ranging from 20 to 35 days based on length of service.
Family and medical leaves of absence.
Paid parental leave.
Commuting benefits.
Employee Discount Program.
Employee Assistance Program (EAP).
Childcare benefits.
May be eligible for discretionary bonuses.