Job Category: Quality Assurance / Quality Compliance / GMP Manufacturing
Reference ID: JR-195527
Location: Mountain Home, Arkansas, United States
Company: Baxter International Inc.
Employment Type: Full-Time
Work Authorization: U.S. work authorization required (no visa sponsorship available)
About the Company
Baxter International Inc. is a global healthcare organization dedicated to improving patient outcomes through high-quality medical products and therapies. Operating in more than 100 countries, Baxter maintains rigorous quality standards across the entire product lifecycle, ensuring compliance with global regulatory frameworks and industry best practices.
The Quality organization plays a mission-critical role in safeguarding patient safety, regulatory compliance, and manufacturing excellence.
Position Overview
The Associate III, Quality Compliance is a mid-to-senior level quality professional responsible for overseeing and managing key compliance functions within a regulated manufacturing environment. This role leads compliance areas including Training, Document Control, Critical Systems, and Calibration programs, ensuring alignment with corporate specifications, GMP regulations, and international quality standards.
The ideal candidate will possess strong regulatory knowledge, leadership capability, and hands-on experience in quality systems within medical device or pharmaceutical manufacturing.
Key Responsibilities
Quality Systems & Regulatory Compliance
Direct and supervise compliance programs including:
Training Management
Document Control
Critical Systems Oversight
Calibration Management
Ensure adherence to:
GMP requirements
Quality System Regulation (QSR – 21 CFR Part 820)
ISO 13485 and EN ISO 13485 standards
Corporate SOPs and internal specifications
Maintain regulatory readiness for internal and external audits.
Audit & Inspection Management
Take direct responsibility for site-level internal and external audit programs.
Interface with regulatory bodies, notified bodies, and third-party auditors including TÜV.
Lead inspection preparation, response coordination, and corrective action implementation.
Risk Management & Continuous Improvement
Evaluate change controls for process, product, and regulatory impact.
Initiate actions to prevent nonconformities and address quality system deficiencies.
Recommend, implement, and verify corrective and preventive actions (CAPA).
Participate in or lead supplier quality assessments.
Leadership & Cross-Functional Collaboration
Coordinate departmental activities within the Quality Compliance organization.
Mentor, train, and develop team members.
Assist in departmental budget planning and resource allocation.
Collaborate closely with Production, QA Management, Corporate Quality, and divisional stakeholders.
Serve as Site Subject Matter Expert (SME) for internal training systems and compliance tools.
Systems & Administrative Oversight
Perform administrative functions within AS400 Document Control systems and exception management programs.
Support electronic documentation and quality records management processes.
Required Qualifications & Experience
Education
Bachelor’s Degree in Science, Engineering, or a related technical discipline required
Equivalent professional experience may be considered
Professional Experience
Minimum 5+ years of experience in a quality, compliance, or operational role within a regulated industry
At least 1–2 years of supervisory or managerial experience
Experience in medical device, pharmaceutical, or life sciences manufacturing strongly preferred
Demonstrated knowledge of GMP, QSR (21 CFR 820), and ISO 13485 standards
Experience interacting with external audit bodies and regulatory inspectors
Core Competencies
Strong understanding of quality management systems (QMS)
Knowledge of CAPA, change control, training compliance, and document control processes
Excellent communication and stakeholder management skills
Ability to influence cross-functional teams and drive quality culture
High attention to detail and critical thinking capabilities
Physical & Workplace Requirements
May require overtime, including evenings and weekends
Extended periods of standing and walking
Frequent use of office systems and computer equipment
Safety-sensitive role under Arkansas regulatory guidelines
Reliable and consistent attendance required
Compensation & Benefits
Base Salary Range: USD $96,000 – $120,000 annually (based on experience, skills, and location)
Comprehensive medical and dental coverage from day one
401(k) with company match
Employee Stock Purchase Plan (ESPP)
Paid time off (20–35 days based on tenure)
Paid parental leave
Educational assistance programs
Employee Assistance Program (EAP)
Flexible workplace benefits in accordance with company policy
Compensation may vary depending on experience, qualifications, and market factors.
Equal Employment Opportunity
Baxter International Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, religion, gender, national origin, disability, veteran status, sexual orientation, or other legally protected characteristics.
Why Apply via ThePharmaDaily.com?
ThePharmaDaily.com connects global pharmaceutical, biotechnology, and medical device professionals with verified career opportunities. This position is optimized for:
Quality Assurance Managers
GMP Compliance Specialists
ISO 13485 Professionals
Medical Device Quality Engineers
Regulatory & Audit Readiness Experts
Advance your career in Quality Compliance within a regulated healthcare manufacturing environment by applying for this opportunity today.
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