Grifols Shared Services North America, Inc Center Quality Manager in Bowling Green, Ohio
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
Center Quality Manager
Responsible for oversight of Quality Systems at the assigned BPC, Inc. Plasma Center and supervision of Quality Assurance Specialist. Ensures compliance with cGMP’s, regulatory requirements and Standard Operating Procedures (SOP’s). Participates in all Center audits. As Manager, Plasma QA, assists with internal audits of other Plasma Centers; assist Management in establishing direction and training of other QA Specialist
Responsible for management and providing guidance, training, and coaching for the assigned center Quality Assurance Specialist.
Mentors, supervises and supports subordinate QAS in performance of center Quality Assurance activities.
Provide leadership and direction for Quality efforts in the assigned Plasma Center; responsible for managing Quality systems and standards and keeping Quality and compliance for center Plasma processes and procedures.
Manage and, if necessary, conduct, on-site Quality Assurance audits, review documentation, and assess compliance with all applicable SOP’s, processes and regulations.
Provide assistance and support to Plasma field and Corporate personnel regarding quality assurance/control compliance issues.
Work closely with Plasma Regulatory and Operations in identifying applicable regulations and requirements for BPC, Inc. Plasma Centers. Interface with other BPC, Inc. sites with regards to policies, procedures and tools.
Responsible for oversight and monitoring of day to day Quality Systems at the assigned BPC Inc. Plasma Center to ensure high quality performance and compliance. Responsible for ensuring all items/duties on QA Check List are regularly performed as required.
Observes processes and ensures center compliance with all applicable state, federal and company-designated requirements.
Oversees Center’s QA Team; organizes, coordinates and holds weekly Center compliance meetings and quarterly QA Team meetings. Reports on status of Quality Systems, discusses Track and Trending reports, and provides feedback on overall quality processes at the Center.
Responsible for maintaining up-to-date all regulatory documents such as SOPs, licenses and certificates; responsible for ensuring all equipment is validated and calibrations are kept current.
Fully trained and responsible for the assigned Centers Quality Systems; such as QA errors, Deviations, CAPAs, Change Controls.
Responsible for tracking and analyzing trends in Center and Quality Systems errors; prepares monthly and quarterly Track and Trending reports for Center.
Approves QA Quality System documents such as Deviations, CAPAs, Change Controls, and Unsuitable Test Results.
Assists Quality Management in direction of QA Specialists.
Regularly keeps Center Management advised on state of compliance at the Center; makes appropriate recommendations to Center Management for quality improvements.
Consults with Center Management on the coordination of Quality Assurance oversight and center operations requirements and timelines.
Monitors and determines potential impact of donor and product safety resulting from non-compliance with cGMPs, SOPs, or other requirements. Reports all findings immediately to Center and Plasma Quality Management.
Responsible for incoming and outgoing product release including plasma units, supplies and equipment.
Ensures quarantine of unsuitable plasma units and proper completion of lookback information.
Holds weekly compliance meetings with Center Management. Keeps Center Management advised on state of compliance at the Center; makes appropriate recommendations to Center Management for quality improvements.
Ensures that Quality Control checks are performed as required and in acceptable ranges for test reagents. Responsible for ensuring CLIA required Proficiency Testing is performed and reported according to timelines and requirements.
Together with Center Management, enforces and ensures employee safety throughout the Center in accordance with EHS procedures.
Works closely with Center Management and Training to ensure appropriate completion of all employees training documentation. Assists with new employee and on-going quality related training, as needed, and as required; schedules and performs new employee and annual Center cGMP training.
Participates in all center audit processes, including internal, external customer or Regulatory agency audits. Assists in writing responses to audit findings as necessary.
Performs internal audits of other Centers as assigned.
Writes, processes, and reviews SOPs, Investigational Reports, and other controlled documents as assigned.
Must be flexible and available as needed during Center hours and days of operation.
Reports directly to the Plasma Regional Quality Assurance Manager/Senior Manager.
Reports indirectly to the Center Manager as a secondary line of responsibility.
Education Requirements : Bachelor’s degree in Biological Sciences or related health sciences preferred; degree can be offset by equivalent experience.
Experience Requirements : Minimum six years’ experience in Plasma industry, or related FDA/CBER regulated industry.
Other Essential Knowledge : Detail oriented, and have knowledge of scientific, medical and regulatory terms; knowledge and understanding of government regulations (FDA, GHA, EMA, cGMP, OSHA, CLIA, etc.), industry initiatives (IQPP), and BPC Inc. SOP’s desirable. Customer service oriented; team player disposition; demonstrated organizational and coordination skills, with close attention to detail and accuracy. Ability to prioritize; professional manner; strong written and oral communication skills.. Excellent problem solving skills with minimal supervision. Ability to use computer and software including word processing, spreadsheet and database.
Contacts :Internal: Frequent contacts with professional staff and/or senior management to exchange information, resolve problems, coordinate projects and negotiate solutions to ensure quality and regulatory compliance. External: Regular contact with regulatory officials and customers during Plasma Center audits.
Direct Work of Others : Guides BPC, Inc. Plasma Center Management and staff to ensure compliance with Quality Systems and SOP’s.
Decision Making : Uses independent judgment to assess compliance with regulatory requirements and SOPs.
Challenges : To remain fully knowledgeable of all quality and regulatory guidelines and compliance documentation and issues. prioritization of workflow; accessing required information. Ensuring that all Center areas follow the regulations with regard to the necessary documentation.
Working Conditions : Traveling required up to 25 percent.
Learn more about Grifols
Req ID: 215428
Type: Regular Full-Time
Job Category: Quality