Hiring: Director, Compliance Company: PCI Pharma Services Location: Bedford, NH Job Posted Time: 2026-09-10 13:51:58 Employment Type: Full-time Target Skills & Keywords : Risk Management About the job Required Skills: •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. •Manages QA Compliance team activities encompassing all internal audits and external compliance and regulatory inspections, as well as vendor and customer audit programs and the Annual Product Quality Review (APQR) program. •Develops technical acumen and decision-making skills in direct reports. •Oversees PCI Pharma’s risk management program including implementation and integration of the relevant risk evaluation into the QMS process, as well as collaboration with Manufacturing and other internal stakeholders. •Leads complex audit, deviation and CAPA investigations. •In collaboration with SMEs, oversees the process impact of audit observations, and associated quality events, as well as adverse events to product quality. •Manages quality event trend reports and metrics to measure key quality attributes. •Accountable for departmental process and system improvement initiatives and collaborates in the enhancement of other key QMS and manufacturing processes to ensure compliance with applicable FDA guidelines and regulations. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!