Quality Systems Manager
Exton, PA, US
6d ago

Manager, Quality Systems Exton, PA Summary : The Manager, Quality Systems has responsibility for development and implementation of Quality Systems.

The successful candidate will work closely with the Vice President, Quality, and the Management Team to develop and implement overall quality systems.

POSITION DUTIES & RESPONSIBILITIES : -Build, develops and implement Quality Systems, activities and resources, including the following : -Implementation of policies, standards and procedures to ensure finished products conform to regulatory standards -CMO Selection and oversight -Auditing -Batch lot review -Deviation and CAPA Management -Document Control -Change Control -GMP Training -Collaborates with cross-functional product development teams to ensure development objectives are established, communicated and achieved.

  • Performs audits of contract manufacturers and contracted laboratories (GLP, GCP and GMP). -Domestic and international travel required (up to 50%) -Provides oversight of contract manufacturing / testing organizations, including providing an on-site presence during critical activities.
  • May be requested to support Quality Operations, based on need and experience. SUPERVISORY RESPONSIBILITIES The Manager, Quality Systems has no direct reports however he / she is expected to lead and coordinate diverse teams.
  • PROFESSIONAL EXPERIENCE & EDUCATIONAL REQUIREMENTS : The Manager, Quality Assurance, must be knowledgeable and capable in the following areas : -cGMP and FDA / EMA biologics regulations, and as applicable other international regulations -Aseptic Processing regulations and guidelines.

    Must be able to evaluate manufacturing conditions and lot-specific data in order to disposition products -Production of biological products -Process and analytical validation -Change management, document control, deviations management, training (including record keeping) and CAPA -Analysis and problem solving - Must have the ability to review and analyze manufacturing, quality control and validation data.

    Participates on, and leads as necessary, cross-functional teams in root cause analysis and solution identification. -Developing effective corrective and preventive actions -Experience with implementation, administration and validation of electronic Quality System Database.

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