Quality Manager

GRIFOLS, S.A.

24d

About The Position

Providing support to the Technical Director to ensure compliance of the Quality Operations, Regulatory and cGMP Compliance Program of Grifols USA. Generates records to comply with regulatory requirements, (cGMP QSR/FDA Quality Standards, Good Distribution Practices and Internal Quality Standard Operating Procedures) within the organization. The position ensures that the quality systems are in compliance with the rules and regulations of the regulatory agencies (FDA 21 CFR, PIC/S GDP) and that the company policies and procedures are being followed.

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).

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

Manages the customers of the distributed BioPharma products to ensure compliance to Good Distribution Practices. This includes qualification and requalification via risk analysis, desk audit or on-site audit.
Works alongside Managed Markets to ensure the distributors of the BioPharma products have an established and current quality agreement.
Tracks the shipping complaints associated with the distribution of BioPharma and HealthCare Solutions product to ensure they are appropriately reported, recorded and resolved on a timely basis.
Creates and updates procedures to ensure the respective departments associated with the distribution of product are appropriately incorporated under the GUSA Quality System. This includes BioPharma and HealthCare Solutions.
Serves as the Training Coordinator (GTP and Manual Training) to establish the Training Profiles of new GUSA employees and distribute and manage the training responsibilities that must be processed manually for GUSA personnel.
Responsible for the review and record keeping of GUSA's Quality Systems records: CAPA, deviation, Complaints, Returns, Inventory Control, review and closure of HealthCare Solutions Hospital Call Center Service Cases.
Assists Technical Director in ensuring the GUSA's Quality System are compliant to the applicable regulations.
Works with HealthCare Solutions Customer Service to ensure suppliers/product/materials are reviewed for Regulatory Requirements by Global Marketing and approved by GUSA for distribution within the United States prior to issuing an SAP Code.
Performs Internal Audits to ensure that the GUSA Quality Systems are compliant to Good Distribution Practices.
Performs Supplier Audits to ensure that the product being supplied to GUSA for distribution within the United States meets the US Regulatory Requirements.
Maintains the Approved Supplier List for GUSA.
Support overall other Grifols divisions (domestically & globally), to ensure a compliant Quality Management Systems, GDP and etc.