Leads and manages employees, ensures staff is fully trained, works with employees to ensure development opportunities occur, and mentors staff.
Manages the Supplier Qualification Program which includes establishing supplier qualification requirements, maintaining supplier lists and certification, and facilitating supplier change notification assessments. This includes but not limited to: contract laboratories and manufacturers, service providers, and material suppliers.
Participates in the development and improvement of corporate policies and procedures for the Paragon Supplier Quality and Auditing programs to assure alignment with current industry expectation and regulations.
Identifies compliance risks and works cross-functionally to identify and implement resolutions. Escalates significant compliance and/or business risks to management.
Oversees external and internal auditing schedules to assure adherence to internal operating procedures and GMP regulations.
Leads/participates in audits.
Presides over internal and external audit commitments, ensuring sustainable compliance.
Maintains, analyzes and develops plans for improving quality metrics for Supplier Quality and Auditing Programs.
Stays current and is an internal subject matter expert for changes in GXP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents (i.e.: ICH, PTC, ISPE, etc.), and best industry practices.
Supports regulatory inspections as necessary.
Build and maintain successful cross-functional relationships with internal customers such as Manufacturing, Analytical, Quality Control, and Facilities Engineering.
Ability and willingness to work in a fast-paced environment
Performs duties related to Corrective and Preventative Action (CAPA) plans, deviations and change control.
Education & Experience:
Bachelor’s degree in biological science or technical discipline.