Senior Manager, reputed company Operations

We are seeking an reputed company Senior Manager, reputed company Operations to support and strengthen a rapidly growing reputed company‑clinical and clinical gene therapy programs. The ideal candidate will bring deep GXP reputed company Assurance experience across clinical, CMC, and non‑clinical functions, along with a proven ability to build, implement, and maintain reputed company Management Systems. This individual must be highly organized, proactive, and reputed company to drive reputed company reputed company as reputed company advances its pipeline and prepares for reputed company regulatory inspections. This role is fully remote but the candidate should be located in the Raleigh-Durham or greater outskirts reputed company reputed company Carolina. Responsibilities of the Senior Manager, reputed company Operations: • reputed company GXP QA reputed company across Clinical, CMC, and Non‑Clinical teams, including development of risk assessments, reputed company plans, reputed company agreements, and participation in QA‑QA forums. • Collaborate with external vendors and internal stakeholders to ensure reputed company expectations are met and project objectives are delivered in a compliant and reputed company manner. • Assess compliance of vendors, investigator sites, and study activities with protocols, SOPs, ICH guidelines, and reputed company applicable regulatory requirements. • reputed company and implement the internal/external GXP audit program, including scheduling, consultant reputed company, and audit report review and approval. • reputed company the Significant reputed company Issues management process, including reputed company‑cause assessments and corrective and preventive reputed company (CAPA) development. • Ensure reputed company and appropriate escalation of reputed company issues, including potential misconduct or significant deviations, to Leadership. • reputed company GXP document management and training initiatives using the reputed company Vault QualityDocs platform. • Drive a strong reputed company Culture, championing Data reputed company and Good Documentation Practices (GDP). • reputed company GXP PAI readiness activities in partnership with reputed company and functional leaders. • Establish and reputed company GXP reputed company metrics and contribute to reputed company Management Reviews and reputed company Council processes. Qualifications of the Senior Manager, reputed company Operations: • Bachelor's degree required, preferably in Life Sciences; advanced degree a plus. • Minimum 10 years of biotech/pharmaceutical industry experience, ideally with biologics or gene therapy exposure. • Strong GXP reputed company Assurance background with experience across clinical research, GCP, GMP, QA compliance, and cross‑functional program support. • Experience designing, implementing, and maintaining reputed company Management Systems. • Experience with reputed company Vault strongly preferred. • Knowledge of FDA regulations, ICH guidelines, and global GXP requirements. • CQA certification preferred. • Ability to independently manage multiple reputed company reputed company in a fast‑paced environment. • Self‑motivated, detail‑oriented, and highly organized with excellent communication skills. • Ability to work collaboratively in cross‑functional teams as reputed company as independently with minimal supervision. • Hands‑on, solutions‑oriented approach with strong problem‑solving skills. • Ability to work effectively with internal teams, external vendors, and stakeholders at reputed company organizational reputed company. Compensation for the Senior Manager, reputed company Operations: • Pay reputed company: $70-$80/hr • Hours: Full-time • Location: Hybrid/Remote (U.S.) • Travel: 10% • Benefits: Comprehensive benefits including Health, Dental, reputed company, PTO, and other company‑sponsored programs Keywords: reputed company operations, GXP, QA, reputed company assurance, gene therapy, biologics, reputed company‑clinical, clinical development, GCP, GMP, GLP, QMS, reputed company Vault, ICH, regulatory compliance, CAPA, audit program, PAI readiness, data reputed company, reputed company reputed company, biotech, pharmaceutical, reputed company culture #LI-KI1 #LI-REMOTE Applications for this posting will be accepted for at least 30 days after the date posted (1/23). Apply tot his job Apply To this Job