Baxter International Inc. · 16 hours ago
Manager, Quality
Skaneateles, NY
Full-time
Onsite
Mid, Senior Level
$112K/yr - $154K/yr
5+ years expBaxter International Inc. is dedicated to redefining healthcare delivery to improve lives. The Manager of Quality will ensure compliance with regulatory requirements, develop and maintain quality systems, and provide leadership in quality assurance initiatives across the organization.
BiotechnologyClinical TrialsHealth CareMedical
Responsibilities
Responsible for ensuring that the company’s operations and activities comply with all relevant laws, regulations, and industry standards within the segment. The role includes ensuring the implementation and maintenance of robust quality systems in accordance with regulatory requirements and industry standards. You will work closely with various departments, including legal, regulatory affairs, quality assurance, and operations, to develop, implement, and maintain effective compliance programs and processes
Develop, implement, and maintain quality systems policies, procedures, and processes to ensure compliance with regulatory requirements, including FDA, and other relevant authorities
Provide strategic leadership and oversight for the management of quality systems, including but not limited to document control, change control, deviation management, CAPA, training, and audits
Training and Education: Design and deliver comprehensive compliance training programs for employees at all levels to promote awareness of compliance obligations and foster a culture of integrity and ethical conduct within the organization
Understands and deploys processes to assure conformance to regulations in a mid to large size plant of a large program or department. Manages regulatory inspections
Risk Assessment and Mitigation: Conduct regular assessments to identify potential compliance vulnerabilities and develop strategies to mitigate risks effectively. Monitor changes in laws, regulations, and industry trends to anticipate and address emerging compliance issues proactively
Monitoring and Auditing: Establish monitoring and auditing processes to evaluate the effectiveness of compliance controls and identify areas for improvement. Lead and participate in internal and external audits, inspections, ensuring timely responses and resolution of any findings or observations
Investigations and Remediation: Lead investigations into compliance incidents, allegations of misconduct, or violations of policies and regulations. Implement corrective actions and remediation plans to address identified issues and prevent recurrence
Collaborate cross-functionally with various departments, including Quality Assurance, Regulatory Affairs, Manufacturing, and R&D, to drive continuous improvement initiatives and ensure alignment with quality objectives
Monitor key performance indicators (KPIs), data analytics and metrics to assess the effectiveness of quality systems and identify areas for improvement
Stay abreast of regulatory developments, industry trends, and best practices related to quality systems, and proactively implement necessary changes to maintain compliance and enhance operational efficiency
Regulatory Reporting and Documentation: Prepare and submit regulatory reports and filings as required by regulatory authorities. Maintain accurate and comprehensive documentation of compliance activities, including policies, procedures, training records, and audit findings
Qualification
Required
Bachelor's degree in a relevant scientific discipline
Minimum of 5 years of experience in quality assurance, compliance, or quality systems management within the pharmaceutical industry, with progressively increasing levels of responsibility
Minimum 2-3 years' 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
Excellent written and verbal communication, presentation, and facilitation skills
Strong negotiation skills and significant experience in 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
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings
Must have basic English written and oral communication skills adequate to communicate with other team members
Strong leadership, communication, and interpersonal skills, with the ability to effectively collaborate and influence stakeholders at all levels of the organization
Preferred
Advanced degree preferred
Experience with electronic document management systems and other quality management software tools is desirable
Preferred Certification in quality management (e.g., ASQ Certified Quality Manager, Six Sigma) is a plus
Benefits
Medical and dental coverage that start on day one
Insurance coverage for 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 (RSP), with options for 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
Company
Baxter International Inc.
For nearly a century, we have delivered on our commitment to saving and sustaining the lives of patients, working alongside clinicians and providers around the world.
10001+ employees
H1B Sponsorship
Baxter International Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (15)
2024 (10)
2023 (17)
2022 (18)
2021 (6)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.28BKey Investors
German Federal Ministry of Education and Research
2025-12-08Post Ipo Debt· $600M
2021-04-21Grant· $1.81M
2019-05-15Post Ipo Debt· $1.68B
Leadership Team
Andrew Hider
President and Chief Executive Officer
Giuseppe Accogli
EVP & Chief Operating Officer
Recent News
HospitalManagement.net
2026-01-16
Company data provided by crunchbase