Compliance Supervisor

PCI Pharma Services•San Diego, CA

1d•$76,000 - $85,500

About The Position

The Compliance Supervisor ensures compliance with applicable domestic and international regulations for drugs, devices, and biologics, with particular focus on FDA, DEA, and other relevant regulatory agency requirements. The role oversees customer and regulatory audits, including preparation, hosting, responses, corrective actions, and timely closure. It communicates audit findings and lessons learned across departments and facilities, maintains Customer Quality Agreements and Site Master Files, and supports programs that promote quality and regulatory compliance. The position also supports continuous improvement, coordinates audits of suppliers with potential cGMP impact, and contributes to inspection readiness. It monitors audit observations and CAPAs for timely completion and effectiveness. The Compliance Supervisor provides day-to-day supervision and guidance to assigned Quality Compliance personnel, including workload prioritization, training, and performance management. Overtime and/or weekend work may be required based on business needs; regular and reliable attendance is essential.

Requirements

Bachelor's degree in a related field and/or 3–5 years of related experience and/or training.
College-level mathematical skills.
Advanced computer skills, including ability to perform complex computer tasks and operate various computer programs.
Full professional proficiency in speaking, reading, and writing for professional needs.
Ability to apply logical or scientific principles to a wide range of intellectual and practical problems, including complex nonverbal symbolism and concrete or abstract variables.
High standard of report writing.

Nice To Haves

Ability to effectively present information to various people as required by the job.
Ability to identify and resolve problems in a timely manner.
Ability to display original thinking and creativity.
Ability to adapt to changing work environments.

Responsibilities

Ensure compliance with applicable domestic and international drug, device, and biologic regulations, particularly FDA, DEA, and other relevant regulatory agency requirements.
Coordinate and oversee customer and regulatory audits, including pre-audit documentation, hosting, audit responses, corrective actions, and timely implementation and closure.
Communicate customer and regulatory audit observations, corrective actions, and lessons learned to applicable departments and facilities.
Review and maintain Customer Quality Agreements to align with regulatory requirements and site operations.
Review and maintain Site Master Files and associated compliance documentation, as applicable.
Support programs that promote a culture of quality and compliance with company policies, procedures, and applicable regulations.
Use continuous improvement tools to identify process improvements and strengthen compliance activities.
Perform or coordinate audits of suppliers with potential cGMP impact under the corporate supplier management program.
Support inspection readiness activities to maintain compliance with regulatory requirements and internal procedures.
Monitor audit observations and associated CAPAs to ensure timely completion and effectiveness.
Supervise and guide assigned Quality Compliance personnel, including prioritizing workloads, providing training, managing performance, and ensuring work is completed accurately and in accordance with procedures.
Maintain knowledge of and adhere to applicable PCI policies, procedures, cGMP, and GCP requirements.
Work overtime and/or weekends as business needs require.
Maintain regular and reliable attendance.
Perform other duties as assigned by Quality Management.