Sr. Quality Specialist

Primary Responsibilities

• 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.
• 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.

Additional Responsibilities

• Support overall other Grifols divisions (domestically & globally), to ensure a compliant Quality Management Systems, GDP and etc.

Knowledge, Skills & Abilities

• Possess certification to a quality professional organization, e.g. ASQ CQA
• Proficient with Good Distribution Practices
• Proficient with FDA Medical Device Requirements (CDRH - Center for Devices and Radiological Health)
• Proficient with FDA requirements for Biologics (CBER - Center for Biologics Evaluation and Research)
• Strong leadership and mentoring skills.
• Excellent project execution skills with an ability to manage multitask and prioritize in a fast-paced environment.

Requirements

• 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).