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).

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