Sr. Manager, Quality Systems and Compliance

Requirements

• Maintain and improve the quality system and provide compliance oversight per FDA 21 CFR part 820, 210, 211, 4 and ISO 13485 requirement
• Oversee and maintain the deviation, CAPA, change control, training, product complain, investigation and non-conformance programs to ensure compliance with internal SOP and regulatory authority requirements
• Create and establish the annual internal audit program
• Trend and report quality metrics for Management Reviews. Implement appropriate enhancements
• Ensures that performance and quality of products conform to established standards and regulatory agency requirements
• Review regulatory requirements documents and provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure continued compliance
• Implement quality system changes to support evolving regulations and international standards
• Participate in regulatory authority inspections
• Lead/coordinate investigations, and the development and implementation of corrective and preventative action (CAPA)
• Work extensively with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis
• Manage and trend product complaints
• Manage supplier qualification program and establish supplier qualification processes, audit plans, quality agreements, quality performance metrics and perform GMP audits to suppliers and service providers
• Support the organization in maintaining a work environment focused on quality that fosters learning, respect, open communication, collaboration, integration, and teamwork
• Ensure an understanding of the external regulatory requirements, in order to adapt product quality strategy accordingly

Qualifications

• Attention to detail and organizational skills
• Good interpersonal and communication skills
• Ability to work as a part of a team
• Ability to multi-task and manage a diverse mix of issues, responsibilities and challenges
• Flexible and adaptable to changing environment and priorities

Education and/or Job Experience

• 10+ years of relevant experience in the pharmaceutical or biotechnology industry, and a Bachelor’s degree in science or related fields
• Strong knowledge of cGMP requirements including 21 CFR 210/211, ICH guidelines and specific regulatory authority requirements (FDA, EMA, EU, PIC/S, ISO)
• Experience with Quality System Regulation 21 CFR 820 and ISO 13485:2016 Quality Management System
• Previous experience with combination products is required
• Must be familiar with: cGMPs, Part 11 compliance, CAPAs, Agency Audits, Internal/external cGMPs, GLP
• Strong knowledge of medical devices, combination products and general pharmaceutical manufacturing
• Strong project management and process improvement skills
• Demonstrate keen understanding of domestic and internal quality systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives
• Experience with Risk Management principles according to ISO 14971
• Prior people management experience
• Excellent verbal, written, interpersonal, organizational, and communication skills are necessary with the ability to influence individual and teams across the organization
• Must demonstrate ability to work independently, make effective decisions