Senior Quality Manager - #256961

Synedgen is a fast-growing pharmaceutical company focused on advancing novel therapeutics from pre-clinical through clinical development. We are seeking a talented Senior Quality Manager to lead our Quality Assurance and Quality Control groups and drive our strategic roadmap toward full GMP readiness. If you thrive in a collaborative, fast-paced environment and enjoy applying risk-based, phase-appropriate quality approaches, we want to hear from you! Key Responsibilities Strategic Leadership: Define and execute the Quality operational plan in alignment with corporate goals to strengthen overall GMP readiness. Direct, mentor, and resource-plan for QA/QC teams. Quality Systems & eQMS: Optimize phase-appropriate Quality systems for pre-clinical and clinical programs. Oversee the updating of procedures, specifications, and reports to support the transition to an eQMS. On-the-Floor & Batch Release: Partner with Manufacturing Operations to ensure adequate QA oversight, line clearance, and master batch record reviews. Ensure deviations, discrepancies, and change controls are resolved prior to batch release. Investigations & CAPA: Lead investigations into deviations, non-conformances, and out-of-specification (OOS) results. Oversee timely implementation of CAPAs and continuous improvement initiatives. Audits & Compliance: Serve as the Subject Matter Expert (SME) on 21 CFR 210/211 and ICH guidelines. Lead internal, vendor, and CRO audits, and support regulatory agency inspections. QC & Data Integrity: Manage site data integrity practices and establish performance trending for QC analytics. Required Qualifications Education: BS/MS/Ph.D. in Life Sciences, Chemistry, Biology, or a related technical discipline. Experience: 5+ years of progressive Quality leadership in the pharmaceutical or biotechnology industry, including direct personnel management. Regulatory Knowledge: Comprehensive understanding of 21 CFR Parts 210 and 211, ICH guidelines, and CMC drug development lifecycles. Core QA Skills: Proven track record with deviations, OOS, CAPAs, change controls, computer systems validation (CSV), and eQMS implementation. Audit Experience: Hands-on experience conducting GMP audits of manufacturing facilities and external vendors/CROs. Requirements & Work Conditions Location: Must work full-time on-site at the facility in Claremont, CA (not eligible for remote work). Eligibility: Proof of US work authorization required for US government contracts (FARs 52.222-54). Must pass a background check and E-Verify. Application Note: A Cover Letter is strictly required for consideration. Three professional references will be requested prior to a final offer. #J-18808-Ljbffr Medix™