Director/Senior Director, GMP Quality Assurance

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Job description

Responsibilities:

• Develop and improve Quality Systems, programs and procedures to ensure compliance with US and international regulatory requirements and operational efficiencies.
• Build, develop, and manage a high-performing Quality team.
• Serve as QA representative on interdisciplinary project team(s).
• Ensure appropriate validation of internal computerized systems.
• Oversee development and maintenance of a GxP compliant document control system.
• Establish metrics to evaluate the effectiveness of Quality Systems.
• Develop processes for identification and management of the most important compliance risks for the GMP function and communicate risks to senior management.
• Facilitate the authoring, implementation, and maintenance of appropriate QA SOPs and Quality Manual, and review other functional SOPs.
• Work with other functions to manage and ensure proper training for GxP processes.
• Manage a robust program for vendor qualification and compliance audits of contract manufacturers, packagers and testing laboratories, including preparation of Quality Agreements.
• Interface with in-house personnel and company's contract manufacturing and test facilities to coordinate and monitor quality aspects of production and testing activities.
• Manage the release and disposition of all drug substances and clinical trial materials and reference standards.
• Support validation activities related to facility, equipment, processes and computerized systems at contract facilities.
• Work across departments and with contract manufacturers to ensure readiness for regulatory inspections and participate in inspections as needed.
• Plan and manage the budget for GMP QA function.
• Maintain currency with quality regulations and guidelines; understand and interpret regulations and guidance related to cGMP and GLPs.
• Communicate and promote a culture of quality and operational excellence.
• Effectively represent Quality to regulatory agencies.

Qualifications:

• Bachelor's degree in relevant scientific discipline is required. An advanced degree is preferred.
• 15+ years of hands on experience with increasing responsibility in QA functions with at least 10 years in a managerial/leadership capacity
• Significant hands on experience with small molecule drug development in a biopharmaceutical company.
• Experience implementing quality systems in a GxP environment, and direct experience with FDA and other health authority inspections.
• Experience establishing validated documentation systems and a strong understanding of 21CFRPart 11 requirements.
• Extensive knowledge of US cGMP and GLP compliance regulations and industry practices, as well as EU GMP requirements.
• Ability to critically evaluate and troubleshoot complex problems and attention to detail.
• Strong leadership and management skills.
• Excellent interpersonal skills with the ability to effectively interact with and influence different functional groups at all levels of management.
• Excellent verbal and written communication skills.

Ability to manage multiple priorities and aggressive timelines