Senior Director, Quality Compliance

Vero Biotech, Inc.; Atlanta (GA); On-site; USD 140,000 - 190,000; Full time

Job summary

Vero Biotech, Inc. seeks a Director, Quality Compliance to lead the Investigation/CAPA program, Post-Market Investigations and Training, ensuring timely completion of investigations with root cause analysis and risk evaluation.

You will head Quality Investigation teams handling NCRs, Deviations, CAPAs, and Post-Market Investigations, participate in internal GMP audits, monitor KPIs, and drive continuous improvement while maintaining regulatory knowledge and fostering a quality culture.

Qualifications

• Bachelor's 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.
• Strong leadership and analytical skills with team-focused attitude.
• Knowledge of FDA regulations (21CFR 820, 211, 210), ISO 13485, Medical Device.
• Proven ability to manage priorities and workflow 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.

Responsibilities

• Lead the Quality Investigation teams that complete NCRs, 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.

Skills

Leadership

Communication

Organizational skills

Analytical skills

Team-focused attitude

Interpersonal skills

Regulatory knowledge

Problem-solving

Decision making

Time management

Education

Bachelor's or Master's in scientific discipline

Job description

Job Details: Job Location: Legal Address TEP - Atlanta, GA, Salary Range: Undisclosed, Travel Percentage: Negligible, 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.