How will you make an impact?

The Regulatory 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).

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.

BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, age, disability, genetic information, veteran status, or any other characteristic protected by law.

Accommodation Statement

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com or calling 727-803-7988 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.