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Conshohocken

    Quality Assurance Manager - Conshohocken, United States - LHH

    LHH
    LHH Conshohocken, United States

    2 weeks ago

    LHH background
    Description

    Our client in Conshohocken is hiring a Quality Assurance Manager to join their team

    Job Type: Full-Time/Permanent

    Hours: Monday – Friday, 8:00 AM – 5:00 PM - Onsite 5 days/week

    Reports To: Director of Quality Assurance

    Summary

    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 for immediate consideration**

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