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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
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.
Highest-signal resume keywords
Quality System ComplianceSupplier AuditsInternal AuditsVeeva QMS ManagementRisk Assessment
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Records ManagementRegulatory ComplianceChange Control ManagementTraining DevelopmentCAPA ManagementDeviation ManagementInventory ControlDocument ControlQuality KPI MonitoringProcedure Development
Soft Skills
Cross-Functional CommunicationTraining CoordinationProblem SolvingCollaborationLeadership
Tools & Technologies
Veeva QMSQuality Management Systems
Industry Keywords
FDA 21 CFRGood Distribution PracticesMedical Device IndustryPharmaceutical IndustryRegulated IndustriesMatrix EnvironmentMulti-Site Manufacturing
About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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).
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Paid time off
- Flexible work arrangements