Sr. Quality Specialist

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Summary 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). The role manages key quality activities including audits, supplier and distributor qualification, change controls, risk assessments, KPIs, and quality system documentation to ensure ongoing regulatory compliance. 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. Manages 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 Maintain and keep current the Approved Supplier List and Product List for GUSA 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). Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience. Occupational Demands Travel: 15% Work is performed in an office and/or a laboratory/manufacturing environment or plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32* miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. #J-18808-Ljbffr Grifols, S.A