Vice President of Quality - Madison - confidential

    confidential
    confidential Madison

    2 days ago

    Pharmaceutical / Bio-tech
    Description

    Position Description:

    The Vice President, Quality serves a pivotal role in providing quality leadership and guidance to all corporate functional areas. The position is responsible for the design, implementation, and oversight of all GxP quality procedures and Quality Systems. The role is responsible for a wide variety of activities to ensure compliance with regulatory requirements that involves oversight of internal activities and resources as well as external vendors.

    This position has oversight of both Quality Assurance groups as well as the Quality Control laboratory function within the organization.

    Key Duties and Responsibilities:

    • Develop and facilitate Quality Systems as delineated in the Quality Manual to support the company's clinical development pipeline and preparations for product commercialization
    • Implement and maintain an overall Quality Management System (QMS) meeting the requirements of activities conducted within the company
    • Develop and oversee the internal Quality Control (QC) lab department and operations
    • Support activities relating to clinical QA GCP regulations at the Pasadena location
    • Ensure systems are in place for conducting and tracking employee training required by GxP regulations
    • Support efforts pertaining to internal design, construction, commissioning, and qualification of GMP facilities
    • Review and approve outsourced contract manufacturing documentation such as validation protocols and reports; master batch records; deviations; analytical methods and methods validation; executed batch documentation; labels; and packaging records
    • Maintain a system for qualification of GxP vendors and coordinate auditing of GxP vendors
    • Ensure an system for GXP vendor qualification
    • Establish Quality Agreements with GMP vendors
    • Lead development and maintenance of service and supplier vendor qualification programs
    • Perform investigations into non-conformances and product deviations
    • Document and determine CAPAs, change controls required for internal cGMP processes as well as oversight of these investigations and corrective actions with external vendors
    • Implement and maintain a validated document control system, and develop SOPs/Work Instructions (WI) across functional areas impacting GMP, GLP, and GCP
    • Lead communication and interaction with Qualified Person (QP) to support investigational and commercial product supply chain in Europe
    • Participate in hosting audits or inspections of the company's QMS by regulatory agencies, development partners and licensees
    • Participate in the established review cycle of QA controlled documents and GxP procedures to assure practices reflect written procedures
    • Keep supervisor abreast of significant issues or developments identified during quality activities, as well as actions to be taken for continuous improvement of quality systems
    • Maintain a working knowledge of government and industry quality assurance codes and standards to ensure compliance to GxP regulations
    • Participate in the establishment and maintenance of an internal system for documentation organization and retention that meets global regulatory requirements and corporate business needs
    • Lead the annual management review of the overall Quality Management System and associated data
    • Hiring, development, and leadership of Quality department staff

    Minimum Qualifications and Educational Requirements:

    • BS in Life Sciences or related discipline
    • 15+ years in QA or compliance with particular experience in cGMP commercial manufacturing environment and with experience in GCP clinical programs for drugs and/or biologics preferred
    • 10+ years in a previous management role
    • Experience with developing a QMS and hosting successful regulatory agency inspections
    • Ability to thrive in a fast-paced environment, with experience in sponsor quality oversight responsibilities for contract vendors across all GxP areas
    • Implementation of internal phase appropriate GMP drug substance manufacturing & testing systems
    • Prior successful management of a Quality Management System for commercial product
    • Drug development through commercial manufacturing compliance experience
    • Excellent oral and written communication skills required
    • Strong computer skills utilizing a Microsoft environment (e.g. Word, Excel, Access, PowerPoint)
    • Familiarity with electronic document managements systems, Part 11 compliance and electronic document archiving systems
    • Ability for occasional business travel

    Preferred Qualifications and Competency Requirements:

    Advanced degree

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