Senior Manager, Supplier Quality & Audits
About the role
As the Senior Director, Divisional Quality Audit & Supplier Quality Programs, you will lead strategic quality initiatives that strengthen compliance, drive risk-based auditing, and enhance supplier quality oversight across a global network of sites and suppliers. This role influences enterprise-wide quality strategy, improves inspection readiness, and proactively identifies and mitigates risks that impact product quality and patient safety. Success will be measured by the effectiveness of audit and supplier quality programs, regulatory compliance, risk reduction, and the development of high-performing teams that support operational excellence.
As part of Baxter's Quality organization, you'll work with a highly collaborative team focused on advancing patient safety, regulatory compliance, and operational excellence. This team partners across the enterprise to identify risks, drive quality improvements, and ensure consistent execution of Baxter's standards worldwide.
Responsibilities
- Lead the divisional internal audit program, including audit strategy, prioritization, planning, execution oversight, reporting, and governance across manufacturing, compounding, and design sites.
- Monitor audit results, compliance trends, quality risks, and inspection outcomes to identify systemic issues and inform risk-based quality decisions.
- Oversee a global auditor network, including auditor qualification, development, and program effectiveness.
- Partner with site and functional leaders to support inspection readiness, remediation activities, and ongoing compliance improvement efforts.
- Provide leadership and oversight for supplier quality programs, including supplier risk management, performance monitoring, quality issues, and remediation activities.
- Collaborate with Quality, Regulatory Affairs, Procurement, Manufacturing, and Operations teams to strengthen quality systems and supplier oversight across the organization.
- Lead and develop teams while balancing quality, compliance, and operational priorities across multiple programs and functions.
- Communicate quality program performance, risks, and key priorities to senior and executive leadership.
Requirements
- Bachelor's degree in Life Sciences, Engineering, or a related technical field.
- 10+ years of experience in Quality, Regulatory Affairs, Manufacturing, or a related regulated industry, including 7+ years of leadership experience and 5+ years of auditing experience.
- Prior experience within the medical device industry is required; experience within pharmaceutical and/or biologics manufacturing environments is preferred.
- Strong knowledge of global regulatory requirements governing medical device manufacturing, with familiarity in pharmaceutical and biologics regulations preferred.
- Demonstrated success leading large-scale quality, compliance, regulatory, or manufacturing organizations, including management of complex compliance issues, risk assessments, and quality improvement initiatives.
- Experience leading regulatory inspections and audit programs across global manufacturing operations, including FDA inspection experience and oversight of multi-site audit programs.
- Expertise in regulated manufacturing environments, with experience supporting product quality, compliance, and inspection readiness.
- Exceptional leadership, communication, and relationship-building skills, with the ability to lead global cross-functional teams, navigate complex challenges, and drive results.
- Ability to travel up to 50%, including domestic and international travel.
Pay
The estimated base salary for this position is $136,000 - $187,000 annually. The estimated range reflects an anticipated salary range for the position. Individual pay is based on location, skills, expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.
Benefits
- Medical and dental coverage starting on day one.
- Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident.
- Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount.
- 401(k) Retirement Savings Plan (RSP) with 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, and paid parental leave.
- Commuting benefits.
- Employee Discount Program.
- Employee Assistance Program (EAP).
- Childcare benefits.