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    QA Compliance Manager - Durham, United States - Cambrex

    Cambrex
    Cambrex Durham, United States

    1 week ago

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    Description

    Overview:

    The QA Compliance Manager is responsible for the inspection readiness program for the assigned site.
    Inspection readiness may include periodic internal audits, client audits, or any external agency
    inspections like the FDA. Has the responsibility to lead audits as well as serve as the primary quality
    representative during external agency or client audits. Accountable to the client and/or agency for audit
    observations responses and the associated corrective measures. or GMP/GDP audits (for Client,
    Regulatory & Internal).

    The QA Compliance Manager works collaboratively with other members of the site, and the clients
    functional areas and leadership teams to evaluate GMP/GDP business operations for compliance with
    health authority requirements, SOPs, and procedures, to ensure product quality and patient safety

    Responsibilities:
    • Reports to the Site Quality Head.
    • Manages, leads, and supports client visits, client audits, regulatory audits and inquiries to ensure
      complete fulfillment of requests and interests. Identifies the scope and associated audit team
      member(s).
    • Generate/Evaluate audit responses to audit observations and ensure that proposed CAPA plans are
      suitable to address the observed deficiency and reduce risk to the business.
    • Review evidence of CAPA completion and evaluate CAPA effectiveness during subsequent audits.
    • Lead and drive continuous improvement of the audit program, and development of tools and
      processes utilized to facilitate the audit process.
    • Authors and negotiates terms of Quality Agreements with clients as needed.
    • Oversees vendor management program, supplier certification and qualify GxP vendors, as needed.
    • Investigates deviations/events, issues and manages Corrective/Preventative Actions. Participates in
      creation and management of changes.
    • Escalate issues to management in a timely manner implementing appropriate solutions, including
      Corrective and Preventative actions.
    • Interpret applicable quality regulations/standards and create appropriate policies and procedures.
    • Maintain current knowledge of updated regulations; industry guidance; and best practices to ensure
      optimal execution of the audit program.
    • Works with the site management in all areas to maintain a cGMP compliant facility in a constant
      state of inspection readiness.
    • Facilitates the development, implementation, and maintenance of procedures and policies to
      comply with FDA, EU, and ICH requirements applicable to sites needs.
    • Creates strong and effective working relationships with Quality team, colleagues and clients.
    Qualifications / Skills::
    • Excellent attention to detail, as well as time and resource management.
    • Excellent personnel and professional integrity and trustworthiness with strong work ethics and the
      ability to independently with minimal direction.
    • Expertise in hosting regulatory and client audits to ensure compliance to regulatory requirements.
    • Experience conducting audits of suppliers to ensure continued supplier quality and ensuring minimal
      disruption to the supply chain, ensuring continued manufacturing and testing processes.
    • Demonstrated knowledge of global GMP and regulatory requirements related to the pharmaceutical
      drug development / manufacturing process.
    • Advanced knowledge of FDA, EU, and ICH requirements and implementation for GLP and GMP in the
      pharmaceutical industry.
    • Experience in documenting, analyzing, and responding to regulatory authorities in all areas of
      compliance.
    • Strong knowledge and understanding of LIMS and Empower, required.
    • Skilled in MasterControl, Trackwise and/or other QMS software applications.

    Skills / Abilities:

    • Demonstrate the capability for continued upward growth and technical contributions.
    • Exceptional analytical and problem-solving skills with the proven ability to think strategically.
    • Demonstrated extensive knowledge and understanding in providing effective evaluation of
      laboratory practices such as raw material, drug substance, drug product and medical device testing,
      compendia methods (e.g. USP/NF, EP, JP), and method validation/qualification/transfer.
    • Effective team and interpersonal skills with the ability to work across numerous scientific and
      management disciplines.
    • Excellent diplomatic, analytical, and communication skills both verbal and written.
      Strong Computer Skills
    • Microsoft Suite, proficiency
    Qualifications:
    • Related BA/BS, required.
    • 8+ years of relevant experience in a CDMO and/or pharmaceutical environment, preferably in
      Quality Assurance.
    • At least 4 years of experience in a leadership role in pharma or biotech.
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