Manager, QMS

Baxter • Round Lake, IL

3d

About The Position

As the Quality Management System (QMS) Program Leader, the Manager, QMS oversees a portfolio of quality system programs that support product quality, regulatory compliance, and operational excellence. The role serves as the site leader for investigation management and provides governance and strategic direction for customer complaints, change control, APQR, and management review processes.

The position establishes effective quality governance, strengthens organizational accountability, develops high-performing teams, and ensures risks are proactively identified, evaluated, and addressed. Success is measured by improved process performance, inspection readiness, data-driven decision-making, and sustained quality system effectiveness in support of 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.
• Proven 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 in 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, 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 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.
• Childcare benefits.
• The position may be eligible for discretionary bonuses.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager