The Quality Assurance Manager holds a pivotal role within our organization, tasked with the critical responsibility of ensuring that all products and services meet the established quality standards.
Responsibilities:
Up-to-date understanding of FDA regulations, cGMP "Current Good Manufacturing Practice" and internal policies/procedures.
Manage deviations, nonconformances, complaints, safety incidents, Corrective and Preventive Actions (CAPAs), and Supplier Corrective Action Requests (SCARs) ensuring prompt investigation and implementation of effective corrective measures.
Conduct thorough root cause analyses and assessments of CAPAs to determine the adequacy of investigations.
Establish, assess, and refine quality metrics, offering insights and recommendations to drive continuous improvement.
Oversee the review of HCT/P donor records to ensure final product release aligns with standard operating procedures and regulatory/accrediting agency requirements.
Supervise the review of quality control records, encompassing equipment cleaning, maintenance, environmental monitoring, and supply inspections.
Contribute to training efforts on quality-related processes and corrective actions.
Support the implementation of new projects and product development initiatives.
Assist in the formulation of validation/qualification protocols and summary reports, adhering to regulatory requirements and industry best practices.
Evaluate and authorize validation/verification protocols, execution data, and summary reports.
Facilitate internal, client, and regulatory agency audits to guarantee compliance with regulatory and certification standards, as well as internal policies and procedures.
Cultivate professional relationships with customers, partners, and vendors.
Oversee direct reports and monitor individual performance.
Maintain meticulous records in accordance with standard operating procedures.
Participate in offsite business meetings and conferences to stay abreast of industry developments and trends.
Education & Experience:
Bachelor's degree required in biological science or related field.
At least 5 years of experience in quality in an FDA regulated environment for HCT/Ps and/or medical devices (or related field), with progressive management responsibility.
Valid Driver's license.
**If you or someone else you know are interested in this role, please send updated resumes to garrett.fitzgerald@lhh.com for immediate consideration**