Regulatory Compliance Manager

Jabil•Hunt Valley, MD

1d•$103,100 - $185,600•Hybrid

About The Position

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.

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
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
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).

Responsibilities

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.

Benefits

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
paid parental leave
company-paid holidays subject to change yearly