Director, Quality Compliance
About The Position
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.
Requirements
- 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.
Responsibilities
- Manage Investigation/CAPA program
- Manage Post-Market Investigations
- Manage Training programs
- Ensure timely completion of investigations including root cause analysis and risk evaluation
- Lead 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
101-250 employees
