Grifols Shared Services North America, Inc Head of Quality in South Bend, Indiana
Grifols is a global healthcare company whose mission is to improve the health and well-being of people. Our three divisions – Bioscience, Diagnostic and Hospital – develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
Job Title: Head of Quality
Communicate corporate Quality/Regulatory initiatives and strategy to their donor centers.
Detect and communicate issues that could be of a systematic nature to other Heads of Quality and the Director of Donor Center Quality.
Act as a liaison for the completion of Regulatory paperwork for their donor centers.
Ensure audit responses from centers and Regional Quality Managers are reviewed and submitted to Compliance.
Assist with and oversee corrective actions to assure they are effective and feasible.
Develop and implement divisional quality strategy with counsel from corporate leadership.
Collaborate closely with General Manager of Operations to create environment compliant collections and to address concerns or improvements.
Provide an overall quality system perspective to the division.
Ensure compliance with all applicable regulations, industry standards and company approved Standard Operating Procedures.
Ensure that division applies SOP revisions timely and correctly through Regional Quality Managers.
Eliminate quality obstacles that impede their centers’ compliant collections.
Monitor and assist in solving center quality/compliance challenges.
Provide standardization of quality metrics/errors/etc. and system/process analysis.
Provide reporting to Director of Donor Center Quality.
Provide input and suggestions for SOP revisions and improvements of quality systems and procedures.
Host external audits, to include domestic and European agencies, when required.
Visit donor centers as needed for support, investigations, etc.
Be accountable for all quality facets of the division, ensuring that compliant, feasible and effective quality systems are in place.
Direct supervision of Regional Quality Managers including training, hiring, performance management and professional development.
Indirect supervision and responsibility for Center Quality Managers in their division.
Frequently drives to site locations and frequent travels within the United States. 50-75% travel required.
Bachelors degree in biology, chemistry, medical technology or other related fields.
Certification with American Society for Quality (ASQ) is beneficial.
Experience in quality assurance, quality systems, quality management, or regulatory management in the plasma collection, pharmaceutical or device industries.
Experience managing remote staff is helpful.
Experience in blood banking and/or plasma industry is preferred.
Residence or relocation in a state within the eastern half of the US is preferred, but not required.
NOTE: This position will support the plasma donor centers within the Grifols Plasma Operations in the North Central Division.
Learn more about Grifols at http://www.grifols.com/es/web/international/home