Grifols Shared Services North America, Inc Regional Quality Manager in Macon, Georgia
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Headquartered in Barcelona, Spain, Grifols has over 20.000 employees in 30 countries. Grifols’ three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.
With the world's largest network of plasma donation centers, Grifols, through its Bioscience Division, is a leading producer of essential plasma-derived medicines for the treatment of rare, chronic, and sometimes life-threatening conditions. To help ensure a reliable and consistent source of plasmaderived medicines worldwide, we have an integrated production process that begins with plasma collection and continues through fractionation and purification at our three facilities located in Spain (Barcelona) and the United States (Clayton, North Carolina, and Los Angeles, California). Key products include immunoglobulins, alpha-1 antitrypsin, albumin, clotting factors and specialty products.
Under the supervision of the Head of Quality, ensure donor centers in assigned region operate in compliance with all applicable regulations, industry standards and company requirements to ensure donor safety and product quality. Uses critical and analytical thinking skills to meet or exceed established quality performance targets in donor centers of responsibility.
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 response 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, external and 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 centers of responsibility. Collaborate with Division Training Manager to ensure quality and compliant training of staff. Identifies training deficiencies and monitors training corrective actions.
Education & Experience
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.
Previous work experience should demonstrate good interpersonal, written and verbal communication skills, proven use of critical and analytical thinking skills. Ability to perform tasks independently with minimal supervision and motivation/initiation to identify and address concerns proactively. Strong knowledge of cGMPs, pertinent federal and state regulations, SOP interpretation and implementation as well as a thorough understanding of quality systems, quality control and quality assurance concepts. Ability to operate a computer keyboard and calculator. Ability to articulate clearly and conduct oral presentations. Must have legible handwriting. Ability to read and write the English language at a professional level.
Timely completion of required administrative tasks (expense reports, timekeeping, travel authorizations, etc.). Other projects and assignments as assigned by Head of Quality
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 73293
Type: Regular Full-Time
Job Category: Quality