Senior Quality Manager - #256961

Medix™; Claremont (CA); On-site; USD 140,000 - 200,000; Full time

Job summary

Synedgen, a fast-growing pharmaceutical company, seeks a Senior Quality Manager to lead QA and QC and drive GMP readiness across pre-clinical through clinical development.

You will define the quality strategy, mentor QA/QC teams, oversee deviations, CAPAs, changes, and audits while ensuring data integrity and regulatory compliance. The role is on-site in Claremont, CA, with collaboration across manufacturing, regulatory, and CRO partners, demanding rigorous risk-based QA practices.

Qualifications

• 5+ years of progressive Quality leadership in pharma/biotech.
• BS/MS/PhD in Life Sciences or related field.
• Strong knowledge of 21 CFR Parts 210/211 and ICH guidelines.
• Experience with deviations, OOS, CAPAs, change controls, CSV and eQMS.
• Hands-on GMP audits of facilities and CROs.

Responsibilities

• Define and execute the Quality operational plan to strengthen GMP readiness.
• Lead QA/QC groups and oversee the transition to an eQMS.
• Ensure batch release oversight, deviations resolution, and line clearances.
• Lead investigations into deviations and CAPA implementation.
• Oversee internal/vendor/CRO audits and support agency inspections.
• Manage site data integrity practices and QC analytics.

Skills

Quality leadership

GMP compliance

Risk management

Data integrity

Audits

Education

BS/MS/PhD in Life Sciences, Chemistry, Biology, or related

Tools

eQMS

CSV

GxP audits

Job description

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.