Director, Quality Compliance & Remediation Excellence

Baxter Healthcare; Deerfield (IL); On-site; USD 176,000 - 242,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Employee stock purchase plan (ESPP)

Paid time off

Paid holidays

Educational assistance

Commuting benefits

Employee discount program

Employee Assistance Program (EAP)

Childcare benefits

Job summary

Baxter Healthcare in Deerfield, IL, seeks a Director, Quality Compliance & Remediation Excellence to lead strategic quality across our pharmaceutical and sterile solutions network. You will partner with site and enterprise leaders to strengthen regulatory compliance and drive remediation programs that yield sustainable improvements across manufacturing operations.

This role requires deep FDA/regulatory experience, sterile manufacturing background, and a track record of leading remediation

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, Engineering, Life Sciences, or related field.
• 15+ years of experience in pharmaceutical manufacturing and Quality.
• 10+ years of leadership in Quality, Compliance, or Regulatory functions.
• Experience leading FDA inspections and interactions with regulators.
• Knowledge of cGMPs, investigations, CAPA, risk management, and data integrity.

Responsibilities

• Lead regulatory compliance and inspection readiness across pharma and sterile manufacturing sites.
• Support FDA/global authority inspections, regulatory responses and remediation.
• Drive complex compliance and remediation programs to closure.
• Provide expertise in investigations, CAPA effectiveness, and quality system performance.
• Support sterility assurance, contamination control, aseptic processing, and microbiological risk management.

Skills

Regulatory leadership

FDA inspections

Quality systems

Data integrity

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy/Science/Engineering

Job description

This is whereyour work makes a difference.

At Baxter, we believe every person - regardless of who they are or where they are from - deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Your Role at Baxter

As the Director, Quality Compliance & Remediation Excellence, you will provide strategic quality leadership across Baxter's pharmaceutical and sterile solutions manufacturing network. You will partner with site and enterprise leaders to strengthen regulatory compliance, ensure inspection readiness, provide independent quality oversight, and lead complex remediation programs that drive sustainable improvements across manufacturing operations.

This role is ideal for a leader with deep FDA and regulatory experience, a strong background in sterile pharmaceutical manufacturing, and a proven track record leading remediation efforts in highly regulated environments.

What You'll Be Doing

• Lead regulatory compliance and inspection readiness activities across pharmaceutical and sterile solutions manufacturing sites.
• Support FDA and global health authority inspections, regulatory responses, and remediation efforts.
• Drive complex compliance and remediation programs to sustainable closure.
• Provide expertise in investigations, root cause analysis, CAPA effectiveness, and quality system performance.
• Support sterility assurance, contamination control, aseptic processing, and microbiological risk management programs.
• Strengthen data integrity practices and promote a culture of quality, compliance, and continuous improvement.
• Serve as a trusted advisor to site and executive leadership on quality and compliance risks.

What You'll Bring

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, Engineering, Life Sciences, or a related field.
• 15+ years of experience in pharmaceutical manufacturing and Quality.
• 10+ years of leadership experience within Quality, Compliance, or Regulatory functions.
• Experience leading FDA inspections and interacting directly with regulatory agencies.
• Proven success leading remediation programs associated with regulatory observations, Warning Letters, OAI classifications, Consent Decrees, or similar regulatory actions.
• Strong knowledge of cGMPs, Quality Systems, investigations, CAPA, risk management, and data integrity.
• Experience supporting sterile pharmaceutical manufacturing operations, including aseptic processing, sterility assurance, contamination control, injectable products, and/or IV solutions.
• Demonstrated ability to influence cross-functional stakeholders and drive sustainable compliance improvements.
• Ability to travel as needed to support pharmaceutical and sterile solutions manufacturing sites, regulatory inspections, and remediation activities.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $176,000 - $242,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, commission, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

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US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and wellbeing benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as 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. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

1 Baxter Parkway|Deerfield, IL 60015|United States of America