Compliance Manager

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

At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, supply chain, and manufacturing solutions. With 60 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

How will you make an impact?

The Compliance Manager ensures the established Quality Management System (QMS) complies with the applicable regulations, industry standards, internal, and customer requirements. This role provides leadership for compliance activities supporting aseptic manufacturing and sterile filling operations, ensuring inspection readiness and continuous improvement of quality systems. The Compliance Manager serves as the primary subject matter expert for regulatory compliance, supporting interactions with regulatory authorities and customers while promoting a culture of quality throughout the organization.

What will you do?

• Ensure compliance with current Good Manufacturing Practices (cGMP), FDA regulations (21 CFR Parts 210 and 211), EU GMP Annex 1, ICH guidelines, and other applicable global regulatory requirements.
• Maintain ongoing inspection readiness for healthcare authorities.
• Lead regulatory inspections and customer audits.
• Coordinate responses to inspection and customer audits observations, including FDA Form 483s, audit observations, and regulatory commitments.
• Monitor changes in global regulations and assess organizational impact.
• Responsible for the Internal Audit program.
• Develop and execute the annual internal audit schedule, conduct audits, track audit findings through effective closure and identify systemic compliance risks and recommend improvements.
• Analyze quality system trends.
• Recommend process improvements that enhance compliance and operational efficiency.
• Provide compliance oversight for aseptic processing and sterile filling operations .
• Ensure compliance with contamination control strategies and cleanroom requirements.
• Participate in investigations utilizing root cause analysis methodologies.
• Promote a culture of quality and compliance.
• Develop cGMP and compliance training programs.
• Mentor departments on regulatory expectations and best practices.
• Support digital quality initiatives and quality system optimization.
• Other duties as assigned by supervisor.

How will you get here?

Knowledge requirements:

• FDA 21 CFR Parts 210 and 211
• EU GMP Guidelines (especially Annex 1)
• ICH Q7, Q8, Q9, Q10
• Auditing
• Root cause methodologies/CAPA
• Data Integrity (ALCOA+)
• Cleanroom classifications (ISO 14644)
• Contamination Control Strategy
• Process and Cleaning Validation
• Media Fill Programs
• Strong understanding of QMS requirements
• Strong critical thinking skills and capable of applying critical thinking to risk-based decisions

Education and Experience:

• Bachelor's degree in pharmacy, microbiology, chemistry, biology, engineering, or a related scientific discipline.
• Minimum 6 years of pharmaceutical (or similar) industry working experience.
• Minimum 4 years in Quality Assurance or Compliance management.
• Minimum 3 years supporting sterile pharmaceutical manufacturing and aseptic filling operations.
• Experience leading regulatory inspections and/or customer audits.
• Experience leading internal audits.
• Experience working with eQMS systems

Physical Requirements:

• - Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• - Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• - Ability to lift, up to, 40 (lbs.) pounds on occasion.
• - Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).

BENEFITS PACKAGE WITH JABIL

• Competitive base salary
• Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options
• 401K match
• Employee Stock Purchase Plan
• Paid Time Off
• Tuition Reimbursement
• Life, AD&DJBL TA - Job Requisition Process Status, and Disability Insurance
• Commuter Benefits
• Employee Assistance Program
• Pet Insurance
• Adoption Assistance
• Annual Merit Increases
• Community Volunteer Opportunity

The pay range for this role is $103,100 - $185,600. Job-related, non-discriminatory factors used to determine the actual offered rate include qualifications and experience, geographic location, education, external market data, and consideration of internal equity.

As part of the total rewards package, Jabil offers benefits to enhance your health, wealth, and resilient self. These include medical, dental, and vision insurance plans; paid time off; paid parental leave; company-paid holidays subject to change yearly; 401(k) retirement plan; and employee stock purchase plan.