Senior Compliance Specialist

About the role

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary of Objective: The Sr. Compliance Specialist supports the execution and maintenance of site compliance programs to ensure adherence to applicable regulatory requirements and company policies within PCI Pharma Services. This role supports internal audits, customer audits, and regulatory inspections, contributing to continuous inspection readiness and compliance with global regulatory requirements (e.g., FDA, DEA, and applicable ex-US authorities). The position contributes to audit lifecycle activities, including audit preparation, execution support, CAPA coordination, and effectiveness tracking, and supports Quality Management System (QMS) activities including investigations, complaints, CAPAs, inspections, quality metrics, and continuous improvement initiatives. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Ensure compliance with domestic and international drug, device and biologic regulations, including FDA, DEA, and applicable ex-US regulatory requirements (e.g., EU GMP), in alignment with PCI Pharma Services operations. Support the execution of the internal and external audit program, including audit preparation, scheduling coordination, and documentation. Lead and support customer audits and regulatory inspections, including audit preparation, logistics coordination, SME readiness, front- and back-room facilitation, audit hosting, and support of inspection responses (e.g., FDA 483 responses). Support the development, tracking, communication, and closure of audit responses, audit observations, and regulatory inspection findings, including associated CAPAs and their effectiveness verification. Lead or support site inspection readiness activities, including participation in mock inspections, gap assessments and training initiatives. Lead or support internal audits (self-inspections) to assess compliance with cGMP, GCP (as applicable), and company procedures. Apply risk-based principles (e.g., ICH Q9) in audit and compliance activities, including prioritization of systems and processes. Support the review and maintenance of Customer Quality Agreements, ensuring alignment with compliance expectations. Support the preparation, review, and maintenance of Site Master Files and other regulatory documentation to ensure accuracy and inspection readiness. Promote and support a quality culture that fosters compliance with company policies and applicable regulatory requirements. Utilize continuous improvement tools and methodologies to support trend analysis, root cause investigations, and compliance improvements. Support trending of audit findings, deviations, and CAPAs to identify potential compliance risks and support Quality Management Review (QMR). Ensure compliance with Data Integrity principles (ALCOA+) and applicable electronic system requirements (e.g., 21 CFR Part 11). Support and contribute to the effectiveness of the Quality Management System (QMS), including investigations, change controls, deviations, CAPAs, and document control. This position may require extra hours and/or weekend work. Attendance at work is an essential function of this position. Performs other duties as assigned by Manager/Supervisor. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: - Strong knowledge of cGMP regulations (21 CFR Parts 210/211) and ICH guidelines (Q7, Q9, Q10). - Experience with risk-based audit programs and inspection readiness activities. - Bachelor's Degree in a related field and/or 3-5 years related experience in a regulated industry. - Minimum of three (3) years of relevant QA experience in a GMP-regulated environment. - Experience supporting internal audits, customer audits, or regulatory inspections - Working knowledge of cGMP regulations (21 CFR Parts 210/211) and applicable ICH guidelines (Q7, Q9, Q10) - Familiarity with Quality Management Systems (e.g., Master Control, Track Wise, Veeva) - Understanding of Data Integrity principles (ALCOA+) including knowledge of 21 CFR Part 11. - Knowledge and hands on experience with QMS data management software such as Master Control, Track Wise, Veeva, etc. - Ability to display excellent time management skills. - Basic Mathematical Skills - Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowl