Grifols Shared Services North America, Inc Regional Quality Manager in Milwaukee, Wisconsin
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.
Regional Quality Manager
● Direct supervision of the Center Quality Managers including hiring, training, performance management, professional development, discipline and termination. Ensure donor centers of responsibility are adequately staffed for quality activities
● Visit donor centers as needed and on a regular basis. Routinely interact with the Center Quality Manager and Center Manager to monitor all established quality activities in place. Ensure quality activities are compliant, effective, feasible and continue to produce desired results.
● Identification of procedural deficiencies and submits corporate-wide change/improvement requests
● Assure compliance with all applicable regulations, industry standards and company approved Standard Operation Procedures. Ensure that SOP revisions are implemented correctly and timely.
● Interact with the Center Quality Manager and center management to develop corrective actions for inspectional findings and assure they are implemented in a timely and effective way. Evaluate adequacy of corrective actions, effectiveness and completeness of reports; assist in root-cause analysis and formulation of corrective and preventative actions. Investigate and propose additional corrective actions in reqponse to emerging quality needs. Monitor compliance of corrective actions where indicated through various analytical systems in place.
● Assure that required proficiency testing is performed, evaluated, reviewed and reported accurately.
● Interact with Center Quality Manager and Center Managers to assure Error Management and Deviation activities and reporting are handled in an appropriate and timely manner.
● Monitor and analyze customer complaints. Track and trend errors, deviations, externand internal audit findings.
● Supply technical and pertinent quality assurance information to external and internal customers. Maintain frequent, timely, thorough and effective communication with the Head of Quality related to quality systems management and issues impacting the quality performance of assigned centers
● Collaborate with the Regional Operations Manager to effectively guide and grow the donor cetners of responsibility. Collaborate with Division Training Manager to ensure quality and compliant training of staff. Identifies training deficiences and monitors training corrective actions.
· Bachelors degree in one of allied sciences (chemistry, biology or medical technology) or related field or professional equivalent such as Registered Nursing /license or Medical Technologist license. Evaluation and/or translation of any foreigh education (high school, college, or professional training) applicable to the position must be provided.
· Minimum 2 years experience in an FDA regulated laboratory, biologics/drug manufacturing, medical device or in-vitro diagnostic environment. Supervisory experience strongly preferred, experience managing remote staff helpful.
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 78511
Type: Regular Full-Time
Job Category: Quality