The Executive Director, Quality Systems and Compliance will support the development, execution and maintenance of the Quality and Risk Management systems, oversee Supplier Quality Management, and lead quality meetings with suppliers.
Support the development, execution and maintenance of the Supplier Quality Management system, including implementing processes to assess the quality and risk of the suppliers.
Provide quality oversight of GMP external manufacturing, testing and storage/distribution suppliers including establishment and maintenance of quality agreements.
Responsible for ensuring compliance with Quality and Regulatory requirements.
Establish, maintain and execute an audit schedule of current suppliers; audit potential new suppliers as part of the supplier qualification process.
Review and approval of manufacturing batch records, analytical records and technical documents, as well as preparation of batch documentation for disposition.
Lead quality meetings with suppliers.
Provide quality guidance and support for change controls, CAPAs and investigations.
Monitor performance metrics and drive continuous improvement.
Maintain current knowledge of industry standards and regulatory requirements for pharmaceutical quality management systems.
Support CMC regulatory filings for drug products.
Provides additional support and assistance on tasks and projects as directed by management.
7+ years’ GMP Quality experience in pharmaceutical industry, including supplier quality, CAPA and Risk Management.
Demonstrated experience managing GMP suppliers, including production of supplier metrics and independent supplier quality audits.
Understanding of, and ability to apply pharmaceutical/biotech cGMP regulations and guidance using a risk-based approach.
ASQ Audit Manager certification is a plus.
Critical thinking and problem-solving abilities.
Excellent decision-making and leadership capabilities.
Effective communication and a reputation for integrity and ethical behavior are critical.
Strong interpersonal skills, a flexible, collaborative, and team-oriented approach to problem-solving, and an ability to work in a fast-paced, rapidly changing environment.
Bias towards start-up experience in a fast-paced environment!
Enjoy the creative process - you’ll be working in constant collaboration.
Exceptional organizational skills and detail-oriented.
Strong written and verbal communicator with key decision-makers.
Self-starter who is driven to address problems and produce solutions.
Travel up to 20% (US and International), dictated by supplier audit and production schedules