Job Information
Grifols Shared Services North America, Inc Regional Quality Manager - Biomat Holdings in RTP, North Carolina
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.
Job Title: Regional Quality Manager
This is a remote based position, candidate must be located in central or eastern coast. Travel will be required.
Summary:
Under the supervision of the Director 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.
Primary responsibilities:
Direct supervision of the Quality Systems 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 Quality Systems 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 Quality Systems 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 Quality Systems Managers 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 Director 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.
Additional responsibilities:
Timely completion of required administrative tasks (expense reports, timekeeping, travel authorizations, etc.). Other projects and assignments as assigned by the Director of Quality.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Requirements:
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.
EXPERIENCE: Typically requires a minimum of 5 years of related work experience in an FDA regulated laboratory, biologics/drug manufacturing, medical device or in-vitro diagnostic environment. Project or technical leadership experience required. Supervisory or management experience preferred, experience managing remote staff helpful.
EQUIVALENCY: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires a Bachelor's degree plus plus 4 years of experience, an equivalency could include 8 years of experience, an Associate degree with 6 years of experience, or a Master's degree with 2 years of experience.
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.
Occupational Demands: May be exposed to short periods of time in freezing temperatures. Limited occupational exposure to blood borne pathogens. Ability to travel via automobile, airplane and/or other ground transportation frequently.
Benefits:
This position is eligible to participate in up to 30% of the company bonus pool. We offer a comprehensive package of benefits including medical, Paid Time Off (PTO), pharmacy, dental, vision, disability insurance, life & AD+D insurance, 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years -- we're growing, and you can grow with us!
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, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Learn more about Grifols (https://www.grifols.com/en/what-we-do)
Req ID: 521354
Type: Regular Full-Time
Job Category: Quality