Sr. Quality Specialist

GRIFOLS, S.A.•NC-RTP, CA

24d•Hybrid

About The Position

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.

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.

Nice To Haves

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.

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