Regulatory & Quality Compliance Lead – GMP/QA

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401K match

Stock Purchase Plan

Paid Time Off

Tuition Reimbursement

Life Insurance

Disability Insurance

Commuter Benefits

Employee Assistance Program

Volunteer Program

Job summary

Jabil is seeking a Compliance Manager to ensure our Quality Management System meets cGMP, FDA, EU GMP, and ICH requirements across aseptic manufacturing. You will lead regulatory inspections and coordinate responses, driving continuous improvement and a culture of quality.

Travel to facilities as needed; mentor teams on regulatory expectations, develop training programs, and support digital quality initiatives to optimize the quality system.

Qualifications

• Bachelor's degree in pharmacy or related science.
• Minimum 6 years in pharmaceutical industry.
• Minimum 4 years in quality assurance or compliance.
• Minimum 3 years supporting sterile pharmaceutical manufacturing and aseptic filling operations.
• Experience leading regulatory inspections and internal audits.
• Experience working with eQMS systems.

Responsibilities

• Ensure cGMP compliance with FDA, EU GMP, ICH guidelines and global regulatory requirements.
• Maintain inspection readiness for health authorities.
• Lead regulatory inspections and customer audits.
• Coordinate responses to inspection observations and CAPAs.
• Monitor changes in global regulations and assess impact.
• Oversee Internal Audit program and schedule.
• Develop and implement quality system improvements.

Skills

Regulatory compliance

Quality Assurance

Auditing

Risk assessment

Education

Bachelor's degree in pharmacy or related scientific field

Tools

eQMS systems

Job description

Jabil is seeking a Compliance Manager to ensure our Quality Management System meets cGMP, FDA, EU GMP, and ICH requirements across aseptic manufacturing. You will lead regulatory inspections and coordinate responses, driving continuous improvement and a culture of quality.

Travel to facilities as needed; mentor teams on regulatory expectations, develop training programs, and support digital quality initiatives to optimize the quality system.