Aseptic Quality & Regulatory Compliance Lead

jabil; Cockeysville (MD); On-site; USD 103,000 - 186,000; Full time

Benefits offered by this job

Medical Insurance

401K match

Paid Time Off

Tuition Reimbursement

Stock Purchase Plan

Commuter Benefits

Life Insurance

Parental Leave

Job summary

Jabil is seeking a Compliance Manager to ensure the Quality Management System complies with FDA, EU GMP, and global requirements. You will lead regulatory inspections, coordinate responses to observations, and promote a culture of quality across aseptic manufacturing and sterile filling operations.

This role requires deep knowledge of cGMP, auditing, and data integrity, with responsibilities spanning internal audits, training, and continuous improvement. Travel to facilities may be required.

Qualifications

• Bachelor’s degree in pharmacy, microbiology, chemistry, biology, or engineering.
• 6+ years of pharmaceutical industry experience.
• 4+ years in Quality Assurance or Compliance management.

Responsibilities

• Ensure cGMP and FDA/EU compliance.
• Lead regulatory inspections and customer audits.
• Maintain inspection readiness across sites.
• Develop and manage internal audit programs.
• Coordinate responses to 483s and regulatory commitments.
• Promote quality culture and training.
• Support digital quality initiatives and QMS optimization.

Skills

Auditing

Root cause analysis

Data integrity

Critical thinking

Education

Pharmacy/QA degree

Tools

eQMS systems

Job description

Jabil is seeking a Compliance Manager to ensure the Quality Management System complies with FDA, EU GMP, and global requirements. You will lead regulatory inspections, coordinate responses to observations, and promote a culture of quality across aseptic manufacturing and sterile filling operations.

This role requires deep knowledge of cGMP, auditing, and data integrity, with responsibilities spanning internal audits, training, and continuous improvement. Travel to facilities may be required.