Director, Quality Assurance and Regulatory Affairs
Location: Memphis, Tennessee
Type: Full Time
Required Education: 4 Year Degree
Government, Regulatory and Code
Employer will assist with relocation costs.
The Director, Quality Assurance and Regulatory Affairs will provide Quality & Regulatory Leadership and will ensure that Quality personnel have the skills and competencies necessary to meet Meridian Life Science (Immunological) present and future needs. The position will ensure that a comprehensive Quality Management System (QMS) is in place to maintain the level of compliance to meet the needs of the Company’s customers and reducing the risk of nonconforming product. The position oversees the Quality & Regulatory (QA, RA, QC, Calibrations, Validations, Document Controls) at all the Meridian Life Science (Immunological) manufacturing sites.
Establishing and maintaining QMS procedures and controls to ensure that the production and quality of products conform to established Company and voluntary
Serving as the Company’s Management
Assessing the effectiveness of the QMS through regular trending analysis of metrics, internal audits, corrective and preventive actions, customer feedback, and other activities as appropriate.
Managing and prioritizing departmental work, including QA batch record review and release of intermediate and final products, to meet internal and external customer
Monitoring metrics for the measurement of Quality Indicators and Quality costs to ensure the effectiveness of the QMS and value to the
Regularly reviewing assay data on manufacturing lines to catch trends and provide necessary guidance to the Operations Group and Leadership team ensure consistency of
Leading the company staff in understanding, developing and employing key quality strategies for continuous
This position will support other Company departments in the identification, control and investigation of non-conformances. The position has the necessary independence, authority and responsibility to enact remediation plans, where
Expert knowledge of ISO 13485, ISO14971, EC1069/2009; EU: EU142/2011, and 21 CFR 820,
and the import and export requirements under the applicable USDA regulations.
Responsible for administration and coordination of daily Quality processes, which result in the improvement and maintenance of the
Define, communicate and enforce quality policies with emphasis on compliance to the Company’s
Manage all communication with regulatory agencies and Competent
Act as the key contact with external auditors, including those of customers and regulatory agencies.
Ensure compliance with applicable national and international standards and
Cooperate with management personnel in formulating and establishing company policies, procedures, objectives and goals regarding Quality Control, Quality Assurance and Regulatory Affairs.
Evaluate contents of reports regarding product assurance issues and confer with management on specific production and/or budgetary
Review technical problems and recommend solutions to problems or changes in procedures regarding quality
Assess both suppliers’ and own company’s product specifications and customer Establish quality requirements of external suppliers; conducting or overseeing supplier qualification audits.
Manage supervisors and managers who supervise employees conducting Quality and Regulatory functions for the business. Responsible for the overall strategic direction, coordination, and evaluation of these
Participate in preparation of department budgets; ensure the department operates within capital and expense budget
Monitor the US and international regulatory environments and provide executive management with assessments of the impact of new and changing regulations on
Work closely with Regulatory and Quality personnel within the Meridian Lifescience and where appropriate Diagnostics business units to support harmonization of Quality Systems and exchange of best
Recruit, supervise, train, develop and retain qualified Quality personnel. Keep department sufficiently
Ensure maintenance of accurate device history
Ensure internal and supplier audits are conducted to applicable standards in a timely manner.
Experience with Master Control Documentation System
Excellent communication skills. Demonstrated ability to articulate ideas clearly and concisely in verbal and written
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Demonstrated ability to prepare scientifically sound, grammatically correct
Ability to respond to inquiries or complaints from customers, regulatory agencies, or members of the business
Education and Experience:
Minimum of a bachelor’s degree is required, preferably in Biomedical Engineering, or a Biological or Life Science
Sound scientific understanding of what is an antigen, antibody, or biological
Working knowledge of standard laboratory test methods such as ELISA, SDS PAGE, pH,
Minimum 10+ years Quality Control, Quality Assurance and Regulatory Affairs related experience including at least 5 years of experience at the senior management
Experience in Biopharmaceuticals, Pharmaceutical or Medical Device Industry
Certification as Lead Auditor to ISO
Facilitator experience for FDA and ISO
Process Excellence and Lean or Kaizen experience preferred; must be able to present quality information using appropriate statistical
Demonstrated ability to prepare well written responses to customer communications and audit findings,
Demonstrated ability to manage and remediate nonconforming product
Demonstrated ability to develop a Quality Management System that is fit for purpose and promotes continuous
Experience in Project Management; Risk Management; Quality Auditing; and Operations Processes are required.
Able to travel up to 20% Domestic or International
Ability to walk up and down several flights of stairs throughout the workday in a multi- location
Must be able to concentrate, analyze and solve complex issues throughout the course of the workday.
Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the
Ability to sit for long periods of time, stoop, reach, bend throughout the course of the workday.
May be required to work outside normal business hours including evenings and/or weekends to support business
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.