Vice President Of Quality

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Job description

Key Responsibilities:

• Lead operations for all aspects of quality, risk management, and product compliance
• Lead and develop the Quality organization ensuring appropriate levels of accountability for decision making and compliance with applicable regulations
• Responsible for providing quality oversight and support to company R&D, product and device development, manufacturing, supply chain, and clinical operations
• Provide quality assurance oversight of Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP) operations (both internal and external) for production and use of regulated pharmaceutical products
• Plan for and host regulatory inspections, as well as external partner GxP, audits
• Maintain quality metrics that monitor progress and ensure high levels of performance and quality are achieved by operational groups and external partners
• Communicate performance related to these targets to other members of management and leadership team on an ongoing basis
• Lead investigations, risk assessments, creation and delivery of GxP training, resolution of complaints, and management of quality issues
• Qualify and manage relationships with contract research/manufacturing organizations and critical suppliers
• Overall responsibility for QMS including SOP development and training, deviation, and CAPA systems
• Understand and support business needs, provide quality guidance and facilitate resolution of quality issues in a timely manner. Provide quality recommendations to compliance issues and/or observations as they arise.

Qualifications:

• BS, preferably in sciences or engineering, plus 15+ years of relevant experience • Demonstrated leadership in Quality Assurance and Quality Control in a biologics manufacturing setting, cell or gene therapy preferred
• Proven record of leadership in managing quality aspects of regulatory filings
• Proven ability to build and develop strong teams, and robust and flexible systems.
• Problem solver who thrives in a fast-paced, agile environment
• Excellent communication skills
• Demonstrated collaborator capable of developing productive cross-functional relationships both internally and with external partners