• Manager Quality Assurance

    Job Locations US-PA-Exton
    Posted Date 2 weeks ago(10/1/2018 11:37 AM)
    Job ID
    2018-1092
    # of Openings
    1
    Category
    Development
  • Overview

    The Manager of Quality Assurance (QA) is responsible for enhancing and maintaining elements of a QA function and Quality Management System (QMS) as required by current Good Manufacturing Practice (cGMP). This role works collaboratively with internal and external stakeholders to ensure cGMP compliance through the routine review/approval of manufacturing deliverables, conduct of audits and providing of quality advisement. The Manager of QA manages and tracks aspects of Idera’s quality system including controlled documents, training, audits, suppliers and metrics. This position reports to the Senior Director, Quality Assurance and is expected to operate with a high level of independence.

    Responsibilities

    60%- cGMP Quality Management

     

    • Ensure the development of QA systems are in accordance with all government regulations and consistent with cGMPs to prepare clinical phase (I, II, and, III) and eventually commercial manufacturing supplies.
    • Facilitate compliance reviews and audit of select CMC documentation (API, Bulk Drug, Packaging/Labeling) for investigational drugs and for product marketing applications respectively.
    • Support timely initiation and tracking of CAPA, event investigations, deviations, OOS and change control.
    • Participate in team meetings with CMO personnel and/or internal stakeholders.
    • Develop and report on quality metrics.
    • Manage/conduct qualifications and audits of CMO partners and ensure timely fulfillment of quality commitments.
    • Support root-cause analysis and verification for corrective and preventative actions necessary to assure conformity with quality specifications.
    • Ensure products are compliant with international cGMP standards.
    • Facilitate the development, review, approval and revision of Quality Agreements.
    • Maintain QA and Master files.

    20%- Enterprise Quality Management

     

    • Faclilitate a robust vendor/supplier management program for the Drug Development functions.
    • Leverage best practices to achieve efficiencies and compliance across the Drug Development functions to achieve operational excellence.
    • Contribute to enterprise-wide quality/compliance initiatives including, but not limited to, risk management, computer system validation, internal assessments/audits, archiving, and training.
    • Support management of third-party QA contractors.
    • Collaborate on development and management of procedural documents (ProcDocs).
    • Provide input and management of Master Audit Schedule.

    15% -Electronic Quality Management System Administration

     

    • Provide administration activities for company electronic Quality Management System (eQMS) in collaboration with QA and IT teams.
    • Contribute to continuous improvement of eQMS workflows.
    • Ensure routine reporting of compliance and trending reports.
    • Support change management and validation as needed.

    5% -Regulatory Agency Inspection Support

     

    • Contribute to development of strategy to ensure a continuous state of inspection readiness.
    • Implement PAI strategies with CMO partners to ensure successful inspection outcomes.
    • Manage/support/host inspection activities at company sites and in collaboration with company vendors.
    • Support post-inspection remediation activities as required.

     

     

    Qualifications

    · Bachelor’s degree in life sciences or related field; advanced degree preferred.

    • Minimum of 7 years’ experience in pharmaceuticals or biologics quality assurance with demonstrated knowledge of international cGMPs.

    · Experience in drug manufacturing and analytical laboratory operations.

    ·Training and experience with international cGMP regulations; knowledge of GLP and GCP a plus.

    ·Experience in transitioning from clinical stage to commercial launch.

     

    ·         Experience in virtual company environment a plus.

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