Regional Quality Manager
NC-North Carolina, US
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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. |
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Regional Quality Manager
50% Travel
Summary:
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.
Responsibilities:
● 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:
Bachelor’s 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 foreign education (high school, college, or professional training) applicable to the position must be provided.
Knowledge, Skills & Abilities:
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.
Experience:
Minimum 8 years of 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.
Occupational Demands:
May be exposed to short periods of time in freezing temperatures. Limited occupational exposure to bloodborne pathogens. Ability to travel via automobile, airplane and/or other ground transportation frequently.
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Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.
Location: NORTH AMERICA : USA : NC-North Carolina:USHOME - Home Address US