Senior Regulatory Remediation Lead

Zvh; United States; On-site; USD 112,000 - 154,000; Full time

Benefits offered by this job

Health coverage

Dental coverage

401(k) with match

ESPP

Education assistance

Paid time off

Paid holidays

Parental leave

Commuting benefits

EAP

Childcare support

Job summary

Baxter is seeking a senior leader to drive remediation programs within a highly regulated manufacturing environment in the United States. You will coordinate cross‑functional teams across Quality, Manufacturing, Engineering, Regulatory Affairs, and IT to address inspection findings, CAPA, and data integrity.

The role emphasizes regulatorily defensible actions and evidence-based closure. You will prepare regulatory responses, governance materials, and leadership updates while guiding site and

Qualifications

• Bachelor’s degree in a related technical discipline.
• 8+ years in regulated manufacturing with quality/regulatory exposure.
• Experience leading cross-functional remediation programs.
• Experience supporting FDA inspections and regulatory responses.
• Strong knowledge of investigations, CAPA, and change control.
• Able to travel as needed for inspections and activities.

Responsibilities

• Lead development, integration, and execution of remediation strategies from inspections and other signals.
• Translate gaps into defined workstreams with owners, milestones, and deliverables.
• Maintain a risk-based remediation master plan with governance cadence.
• Provide independent Quality oversight ensuring plans are sound and regulatorily defensible.
• Drive cross-functional execution to remove barriers and align with commitments.
• Coordinate preparation and Quality review of regulatory responses and evidence packages.
• Identify themes and opportunities to simplify controls without compromising compliance.

Skills

Quality leadership

Regulatory experience

cGMP knowledge

Cross-functional leadership

Project management

Data integrity

Risk management

Regulatory readiness

Education

Bachelor's degree in Pharmacy, Chemistry, Microbiology, Engineering, Life Sciences, Quality

Master's degree preferred

Tools

eQMS

Job description

Baxter is seeking a senior leader to drive remediation programs within a highly regulated manufacturing environment in the United States. You will coordinate cross‑functional teams across Quality, Manufacturing, Engineering, Regulatory Affairs, and IT to address inspection findings, CAPA, and data integrity.

The role emphasizes regulatorily defensible actions and evidence-based closure. You will prepare regulatory responses, governance materials, and leadership updates while guiding site and