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Manager, Quality

https://www.baxter.com/ Logo

Baxter

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Location:
United States , Skaneateles Falls

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

112000.00 - 154000.00 USD / Year
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Job Description:

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Job Responsibility:

  • Ensure the company’s operations and activities comply with all relevant laws, regulations, and industry standards within the segment
  • Ensure the implementation and maintenance of robust quality systems in accordance with regulatory requirements and industry standards
  • 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
  • Design and deliver comprehensive compliance training programs for employees at all levels
  • 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
  • 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
  • Establish monitoring and auditing processes to evaluate the effectiveness of compliance controls
  • Lead and participate in internal and external audits, inspections, ensuring timely responses and resolution of any findings or observations
  • Lead investigations into compliance incidents, allegations of misconduct, or violations of policies and regulations
  • Implement corrective actions and remediation plans
  • Collaborate cross-functionally with various departments 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
  • Stay abreast of regulatory developments, industry trends, and best practices related to quality systems
  • Prepare and submit regulatory reports and filings as required by regulatory authorities
  • Maintain accurate and comprehensive documentation of compliance activities

Requirements:

  • Bachelor’s degree in a relevant scientific discipline
  • advanced degree preferred
  • 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
  • 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
  • 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

Nice to have:

  • Certification in quality management (e.g., ASQ Certified Quality Manager, Six Sigma)
  • Experience with electronic document management systems and other quality management software tools
What we offer:
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • 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

Additional Information:

Job Posted:
January 29, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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