Quality Site Head
Job Category: Quality Leadership / Pharmaceutical / Medical Device
Reference ID: JR-192164
Location: Medina, New York, United States
Company: Baxter International Inc.
Employment Type: Full-Time
Work Authorization: U.S. work authorization required (no visa sponsorship available)
About the Organization
Baxter International Inc. is a global leader in healthcare and pharmaceutical manufacturing, committed to producing high-quality medical products that improve patient outcomes. With operations spanning worldwide, Baxter prioritizes regulatory compliance, operational excellence, and continuous innovation while fostering a culture of collaboration, trust, and accountability.
Position Overview
The Quality Site Head serves as the senior leader responsible for all quality functions at the Medina, NY facility. This role ensures the integration of site-specific quality systems into Baxter’s global quality framework, drives compliance with regulatory requirements, and promotes a culture of continuous improvement. The Quality Site Head acts as the Management Representative for the site, overseeing quality operations, regulatory inspections, and strategic initiatives to achieve measurable quality objectives.
This position is ideal for an experienced quality professional with a proven record of leadership in pharmaceutical or medical device manufacturing.
Key Responsibilities
Develop, implement, and deploy comprehensive quality systems, including CAPA, design control, management review, and process control.
Integrate site-level quality processes with Baxter’s global quality framework.
Oversee regulatory compliance, support inspections, and ensure corrective actions are effectively implemented.
Collaborate with cross-functional teams including R&D, Manufacturing, and Marketing to assess and mitigate quality risks.
Conduct periodic evaluations of quality systems, recommending improvements to executive management.
Provide guidance and oversight for CAPA programs, deviations, and quality investigations.
Identify potential compliance or operational challenges and implement timely corrective actions.
Lead continuous improvement initiatives to enhance process efficiency, product quality, and regulatory adherence.
Communicate quality objectives, progress, and risk mitigation strategies to leadership and key stakeholders.
Required Qualifications & Experience
Bachelor’s degree in Science, Engineering, or related field.
Minimum 10 years of experience in Quality, Manufacturing, or related roles in the Pharmaceutical or Medical Device industry.
7+ years of management experience with responsibility for leading quality teams.
Strong knowledge of regulatory frameworks, quality systems, and industry standards.
Proven track record in strategic planning, quality system implementation, and regulatory inspection readiness.
Excellent analytical, problem-solving, and decision-making skills.
Strong leadership, communication, and stakeholder management capabilities.
Ability to drive a culture of continuous improvement and compliance across a mid-to-large scale manufacturing facility.
Compensation & Benefits
Estimated base salary: $158,000 – $209,000 annually, with eligibility for discretionary bonuses and long-term incentives.
Comprehensive health coverage including medical, dental, and vision from day one.
401(k) Retirement Savings Plan with company match and Employee Stock Purchase Program (ESPP).
Paid holidays, vacation, parental leave, and tuition reimbursement.
Flexible workplace policy with a balance of onsite and remote collaboration.
Additional benefits include commuting support, childcare assistance, employee discounts, and wellness programs.
Equal Employment Opportunity
Baxter International Inc. is an equal opportunity employer. All qualified applicants will be considered without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, veteran status, disability, or any other legally protected characteristics.
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