Compliance Manager

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.

• 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.

• 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

•     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).