Senior Manager Quality External Supply - Allentown - Germer International - Pharmaceutical Recruiting

    Description

    Sr. Manager Quality, External Supply

    Please read the following job description thoroughly to ensure you are the right fit for this role before applying.

    This role must be onsite 3 days a week

    Key Responsibilities

    • Demonstrate strong knowledge of cGMPs, applicable GxPs, and pharmaceutical distribution processes.
    • Perform routine quality audits of CMOs, including follow-up and timely closure of CAPA actions.
    • Establish and maintain quality standards aligned with current regulatory requirements and management expectations.
    • Ensure implementation of the Quality Policy, Quality Management System (QMS), SOPs, and GMP regulations across External Supply and satellite Quality operations.
    • Lead and/or support meetings with external manufacturing organizations to review manufacturing status, complaints, and non-conformances.
    • Manage internal and external change controls, including impact assessments and approvals.
    • Coordinate technically with cross-functional teams to expedite resolution of complaints, deviations, change controls, and investigations.
    • Prepare, review, and maintain quality documentation, including Quality Agreements.
    • Manage non-conformance and complaint investigations at external sites, including initiation and tracking within internal systems.
    • Support changes to specifications, processes, or procedures at external sites, including initiation of internal tracking documents, assignment of action items, and project closure.
    • Provide final product disposition, including review of externally generated batch records and analytical testing results.
    • Manage stability programs for externally manufactured products, including review and evaluation of stability data.
    • Review and/or approve Annual Product Quality Review (APQR) documents for externally manufactured products and support Regulatory Affairs with Annual Reports.
    • Conduct internal audits and participate in regulatory audit preparation, including CAPA development and ensuring timely CAPA closure.
    • Review and approve artwork and labeling, ensuring only current, approved versions are used.
    • Lead supplier qualification and approval, including audit planning, execution, documentation, and tracking of audit findings to closure.
    • Support CMOs and internal functions (Supply Chain, Technical Operations, Regulatory Affairs) in process validation, API qualification, and related activities.
    • Support Business Development and Sales for product launches in new markets by ensuring timely quality deliverables and effective CMO communication.
    • Represent Quality Assurance in CMO-related projects, including technology transfers, providing guidance on quality requirements and reviewing transfer protocols and reports.
    • Support CMO Quality Operations activities, including SOP development, document management, training, and implementation. xhmxlyz
    • Contribute to new quality initiatives and support development of long-term quality strategy.

    Requirements:

    • 14-16 years working experience in a regulated Pharmaceutical Company in GMP environment
    • Hands on experience of quality systems in a GxP environment, and direct experience with USFDA and other health authority inspections
    • A minimum of (5) years of experience in overseeing quality operations for sterile and aseptically manufactured pharmaceutical products

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