Manufacturing Compliance Leader: CAPA, Audits & Quality Systems

1001 Baxter Healthcare Corporation; United States; On-site; USD 90,000 - 115,000; Full time

Benefits offered by this job

Health and dental coverage

401(k) retirement plan

Paid time off 20–35 days

Job summary

Baxter is seeking a Manufacturing Compliance Superintendent to lead CAPA writers and investigators, improving the quality system and preventing nonconformances. You will report to the Manufacturing Compliance Site Lead and guide a team to ensure timely closures and regulatory readiness.

Responsibilities include strengthening procedures, risk assessments, trend reviews, and interactions with auditors while partnering with cross-functional teams to sustain compliant operations across the site.

Qualifications

• Experience in quality systems management and remediation activities.
• Strong knowledge of cGMP, ICH guidelines, pharmacopeial standards.
• Experience leading a team of subject matter experts.

Responsibilities

• Ensure nonconformance and exceptions are initiated and completed timely.
• Develop, implement, and maintain procedures to ensure regulatory compliance and improve execution.
• Provide strategic leadership for batch release and related control systems.
• Design updates to procedures and controls and oversee investigations and CAPAs.
• Interface with auditors and collaborate with cross-functional teams to maintain documentation.
• Assist the site Quality Compliance Lead in implementing regulatory compliance initiatives.

Skills

Quality assurance

Regulatory knowledge

People management

Audit readiness

Communication

Cross-functional collaboration

English/French bilingual

Education

Bachelor’s degree in Chemistry/Pharmaceutical Sciences

Tools

TW8

Quality management software

Job description

Baxter is seeking a Manufacturing Compliance Superintendent to lead CAPA writers and investigators, improving the quality system and preventing nonconformances. You will report to the Manufacturing Compliance Site Lead and guide a team to ensure timely closures and regulatory readiness.

Responsibilities include strengthening procedures, risk assessments, trend reviews, and interactions with auditors while partnering with cross-functional teams to sustain compliant operations across the site.