Senior Director, Quality Compliance

Position Summary

The Director, Quality Compliance is responsible for the day-to-day management of the Investigation/CAPA program, Post-Market Investigations, and Training programs. Responsible for ensuring timely completion of investigations including root cause analysis and risk evaluation.

• Lead the Quality Investigation teams that complete NCR's, Deviations, CAPAs, and Post-Market Investigations.
• Lead the Company-wide QMS Training program.
• Actively participate in the closure of investigations, root cause analyses, and implementation of corrective/preventive actions.
• Ensure timely completion of investigations in accordance with established company timelines.
• Maintain knowledge of current regulatory requirements pertaining to drug/device manufacturing and communicates requirements to associate staff members.
• Participate in routine internal audits of GMP systems.
• Monitor KPIs and perform data trending for quality metrics.
• Review and provide input for revisions to SOPs following assessments of systems and through conducting of investigations.
• Participate in continuous improvement objectives to assure compliance with regulations.
• Lead and mentor quality personnel, including promotion of quality culture and supporting quality objectives
• Practices and promotes Good Manufacturing Practices.
• Other duties as assigned.

Qualifications

• Bachelors or master's degree in scientific discipline.
• Minimum 8 years' experience in FDA regulated industry.
• Minimum of 2 years leadership experience.
• Demonstrated organizational and communication skills.
• Must possess strong leadership and analytical skills with team-focused attitude.
• Demonstrated knowledge of FDA regulations (21CFR 820, 211, 210), ISO 13485, Medical Device
• Proven ability to manage priorities and workflow and handle multiple projects and meet deadlines.
• Ability to work independently and as a member of various teams and committees.
• Proven leadership and business acumen skills.
• Ability to deal effectively with diverse group of individuals at all organizational levels.
• Exceptional writing and interpersonal relationship skills
• Experience with direct contact with FDA and other regulatory bodies
• Good judgement with the ability to make timely and sound decisions.
• Creative, flexible, and innovative team player.