Compliance Supervisor

Essential Duties and Responsibilities

• Ensure compliance with applicable domestic and international drug, device, and biologic regulations, with a strong focus on FDA, DEA, and other international regulatory agency requirements.
• Coordinate and oversee the customer and regulatory audit program, including pre-audit documentation, hosting audits, coordinating audit responses, documenting corrective actions, and ensuring timely implementation and closure.
• Maintain a systematic approach to communicating customer and regulatory audit observations, corrective actions, and lessons learned to applicable departments and facilities.
• Review and maintain Customer Quality Agreements to ensure alignment with applicable regulatory requirements and site operations.
• Review and maintain Site Master Files and associated compliance documentation.
• Support the implementation and maintenance of programs that promote a culture of quality and compliance with company policies, procedures, and applicable regulations.
• Utilize continuous improvement tools to identify opportunities for process improvements and strengthen compliance activities.
• Perform or coordinate audits of suppliers identified as having potential cGMP impact in accordance with the corporate supplier management program.
• Support ongoing inspection readiness activities to ensure the site maintains compliance with applicable regulatory requirements and internal procedures.
• Monitor and follow up on audit observations and associated corrective and preventive actions (CAPAs) to ensure timely completion and effectiveness.
• Provide day-to-day supervision, guidance, and oversight of assigned Quality Compliance personnel, including workload prioritization, training, performance management, and ensuring activities are completed accurately and efficiently.
• Maintain knowledge of and adherence to all applicable PCI policies, procedures, cGMP, and GCP requirements.
• This position may require overtime and/or weekend work based on business needs.
• Regular and reliable attendance is an essential function of this position.
• Perform other duties as assigned by Quality Management.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position.

Required

• Bachelor's Degree in a related field and/or 3-5 years related experience and/or training.
• College Level Mathematical Skills
• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.
• High Standard of Report Writing

Preferred

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