Superintendent, Compliance
Baxter International Inc.
Summary
As Manufacturing Compliance Superintendent, you will report to the Manufacturing Compliance Site Lead, leading a team of CAPA writers and investigators intent on improving execution of the quality system as well as improving existing processes and identifying solutions to prevent further nonconformances and exceptions. You will ensure compliance with the company's global QMS and execute the compliance strategy for the site.
Job description
What you will be doing
As the Manufacturing Compliance Superintendent for Baxter Healthcare, your primary responsibilities include ensuring nonconformance and exceptions are initiated and completed timely. The output of those records and trend reviews will focus on developing, implementing, and maintaining procedures and systems to ensure compliance with regulatory requirements in addition to improving execution and reducing nonconforming events as a strategic approach to the role.
- Provide strategic leadership for batch release (focused on records holding batches), control systems, documentation updates, investigations and the output CAPAs associated with process gaps or improvements
- Design and deliver comprehensive updates to existing procedures and controls, or deploy processes to assure conformance to regulations
- Conduct risk assessments and establish trend reviews
- Interface with auditors and oversee and review investigations
- Collaborate with cross-functional teams and analyze performance indicators
- Maintain comprehensive documentation of compliance activities
- Support the site Quality Compliance Lead to implement and improve regulatory compliance initiatives and complete timely audit responses
Your Profile
- Bachelor's degree or equivalent experience in Chemistry, Pharmaceutical Sciences, or a related scientific field is required
- Minimum of 5 years of experience in quality assurance, compliance, or quality systems management within the pharmaceutical industry
- Minimum 2-5 years of experience managing people
- In-depth knowledge of relevant regulatory requirements, including cGMP, ICH guidelines, and pharmacopeial standards
- Proven track record of successfully managing and implementing quality systems initiatives, including process improvements and compliance remediation activities
- Experience with electronic document management systems (e.g., TW8) and other quality management software tools is desirable
- Experience with regulatory inspections and preparedness
- Experience leading a team of experts and supporting, mentoring, and developing team members
- Ability to strictly adhere to dedicated timelines
- Excellent written and verbal communication, presentation, and facilitation skills
- Strong negotiation skills and significant experience interacting with regulatory authorities
- Risk identification and problem-solving skills
- Demonstrated ability to lead, mentor, and develop others for future growth and development
- Established relationships with regulatory authorities
- Ability to understand verbal and written safety and quality instructions and read and comprehend written work instructions, including words and drawings
- Proficiency in English and French written and oral communication skills
Requirements
- Bachelor's degree or equivalent experience in Chemistry, Pharmaceutical Sciences, or a related scientific field
- Minimum of 5 years of experience in quality assurance, compliance, or quality systems management within the pharmaceutical industry
- Minimum 2-5 years of experience managing people
- In-depth knowledge of cGMP, ICH guidelines, and pharmacopeial standards
- Proven track record managing and implementing quality systems initiatives, including process improvements and compliance remediation
- Experience with regulatory inspections and preparedness
- Experience leading a team of experts and supporting, mentoring, and developing team members
- Ability to strictly adhere to dedicated timelines
- Excellent written and verbal communication, presentation, and facilitation skills
- Strong negotiation skills and significant experience interacting with regulatory authorities
- Risk identification and problem-solving skills
- Demonstrated ability to lead, mentor, and develop others
- Established relationships with regulatory authorities
- Ability to understand verbal and written safety and quality instructions and read and comprehend written work instructions
- Proficiency in English and French written and oral communication skills
- Experience with electronic document management systems (e.g., TW8) and other quality management software tools is desirable
Benefits
- Medical & Dental Coverage
- Life Insurance
- Accident Insurance
- Short & Long-Term Disability
- Business Travel Accident Insurance
- Employee Stock Purchase Plan
- 401(k) Matching
- Flexible Spending Accounts
- Educational Assistance
- Paid Holidays
- Paid Time Off
- Family & Medical Leave
- Paid Parental Leave
- Commuting Benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare Benefits
Company overview
Baxter International Inc. is an American multinational healthcare company headquartered in Deerfield, Illinois, founded in 1931. As a leading global medical device manufacturer, Baxter specializes in developing and producing essential medical products for treating chronic and acute medical conditions. The company operates across three primary business segments: Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. Baxter's extensive product portfolio includes intravenous (IV) solutions, infusion pumps, dialysis equipment for kidney disease treatment, surgical technologies, and hospital pharmaceuticals. With approximately 38,000 employees worldwide and annual revenues exceeding $10 billion, Baxter plays a critical role in global healthcare infrastructure. The company is particularly known for its leadership in IV fluid production, manufacturing approximately 60% of the intravenous fluids used in the United States. Baxter's innovations include pioneering developments in artificial kidney technology and advanced surgical products, serving healthcare providers across more than 100 countries. The company maintains a strong commitment to research and development, investing significantly in medical technology advancements that improve patient outcomes and healthcare delivery efficiency.