Senior Quality Specialist

• Supports the Technical Director in maintaining a compliant Quality System for Grifols USA (GUSA) in accordance with FDA 21 CFR and Good Distribution Practices (GDP).
• Conduct Supplier Audits to ensure products distributed comply with U.S. regulatory requirements and applicable procedures.
• Perform Internal Audits to ensure GUSA Quality Systems are compliant with Good Distribution Practices (GDP) and applicable procedures.
• Support Distribution Quality System records, including CAPAs, deviations, and complaints, ensuring they are properly reported, documented, and resolved in a timely manner.
• Support returns management and inventory control activities to ensure traceability and GDP compliance.
• Manage customers of distributed medicinal products to ensure compliance with GDP, including qualification and requalification through risk assessments, desk audits, and on‑site audits.
• Manage change controls within the Veeva QMS system.
• Manage the qualification and requalification of distributors, 3PLs, product and service providers, and transportation partners in accordance with regulatory requirements and Global Marketing decisions; ensure all (re) qualification records are maintained and archived per established procedures.
• Perform and maintain annual risk assessments related to distribution activities.
• Develop, review, and update procedures to ensure departments involved in product distribution are appropriately integrated into the Quality System.
• Assist the Technical Director in ensuring Quality System remains compliant with applicable regulatory requirements.
• Serve as Training Coordinator by establishing training profiles for new employees and ensuring new or revised procedures are assigned within the training system.
• Develop and deliver training presentations to cross‑functional departments to communicate quality system updates, including new corporate procedures and regulatory requirements that may impact operations.
• Supports Quality KPI monitoring and reporting.

• B.S. in a life science related field.
• 8 years extensive experience working in domestic and global quality operating and manufacturing efforts in a matrix environment within medical device and pharmaceutical "regulated" industries.
• Proven track record of performing and maintaining quality records that comply with regulatory requirements resulting in enhanced safety, profitability, productivity and quality.
• Experience in working with multi‑site manufacturing facilities for medical device companies (start‑up, mid size and High‑volume manufacturing).

Demonstrates expertise in maintaining compliant Quality Systems in accordance with FDA regulations and Good Distribution Practices, with a strong focus on supplier and internal audits, risk assessments, and training coordination.

• Quality System Compliance
• Supplier Audits
• Internal Audits
• Veeva QMS Management
• Risk Assessment

• Quality Records Management
• Regulatory Compliance
• Change Control Management
• Training Development
• CAPA Management
• Deviation Management
• Inventory Control
• Document Control
• Quality KPI Monitoring
• Procedure Development

• Cross-Functional Communication
• Training Coordination
• Problem Solving
• Collaboration
• Leadership

• FDA 21 CFR
• Good Distribution Practices
• Medical Device Industry
• Pharmaceutical Industry
• Regulated Industries
• Matrix Environment
• Multi-Site Manufacturing

• Veeva QMS
• Quality Management Systems