Marketing Coordinator
Snowflake
Spark
Senior Manager, Global Supplier Quality Management (GSQM) - West Coast, Remote, USA
Evotec
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $112,560 - $154,100 per year
Job Level
Senior
Tech Stack
Spark
About the role
- Lead the global supplier quality team, managing the GMP supplier lifecycle: selection, onboarding, requalification, and risk management
- Schedule and oversee supplier audits, ensuring timely completion and compliance
- Manage contracts and consultant auditors supporting GMP audits and international inspection readiness
- Oversee internal GMP Supplier Quality events (e.g., complaints, deviations, CAPAs) with escalation of critical issues affecting patient safety, product quality, or supply
- Act as project manager for assigned quality initiatives, including Change Control Review Board, GMP QMR, and Quality Risk Management
- Assess and ensure external supplier readiness for health authority inspections and client audits - represent QA in internal and external meetings
- Perform and approve impact and risk assessments
- Serve as Business Process Owner (BPO) and Subject Matter Expert (SME) for supplier quality, including system and tool deployment
- Develop, maintain, and deliver controlled documents and training materials for the Supplier Quality Management program
- Support audits and inspections, including preparation of responses and corrective actions
- Communicate deliverable status to clients, management, and stakeholders
- Monitor and report global Supplier Quality Management metrics; support site-level compliance
- Conduct periodic reviews of the Supplier Quality program and drive continuous improvement
- Oversee investigations of supplier-related quality issues and root causes
- Travel to JEB sites as required
Requirements
- Bachelor’s degree with 8+ years in Quality and 10+ years in the biotech industry
- Expertise in Supplier Quality Management processes and methodologies
- Strong knowledge of biologics and pharmaceutical regulations, risk management, and science-based decision-making
- Project management experience
- Proficiency in Microsoft Office and electronic quality management systems (e.g., Veeva QualityDocs, eQMS)
