Quality Systems Manager

PCI Services•Philadelphia, PA

52d

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Quality Systems Manager is responsible for overseeing and maintaining the Electronic Quality Management System (eQMS) to ensure compliance with regulatory requirements and industry standards. This role leads the implementation, administration, and continuous improvement of quality systems processes including Deviations, Change Controls and Corrective and Preventative Actions (CAPA). The Manager will also drive initiatives to analyze quality data, identify trends, and implement improvements that enhance product quality and operational efficiency while developing employee competencies through targeted training programs.

Requirements

Bachelor's Degree in a related field (Science, Engineering, or Quality) and 5-10 years related experience in a regulated environment
Demonstrated expertise in quality management systems and regulatory requirements (FDA, ISO 13485, Medical Device Directive)
Strong knowledge of cGMP and other applicable regulations
Experience with electronic quality management systems, preferably Master Control
Excellent analytical and problem-solving skills with the ability to identify trends and implement improvements
Strong leadership skills with experience managing and developing teams
Exceptional written and verbal communication skills
Advanced computer skills and proficiency with quality management software

Responsibilities

Manage and administer the Electronic Quality Management System (eQMS), ensuring all related documentation is compliant with applicable procedures and regulations
Co-Chair Change Control and CAPA review boards, providing leadership in decision-making processes
Develop, implement, and maintain robust quality metrics to drive continuous improvement within the quality systems
Conduct trend analysis of nonconformances, deviations, and complaints to identify patterns requiring systemic solutions
Ensure compliance with FDA regulations, ISO 13485, Medical Device Directive, and other applicable standards and regulations
Manage the CAPA system to ensure appropriate investigation, implementation, closure, and effectiveness checks meet required timelines
Analyze root causes of quality issues and implement effective corrective and preventative actions
Track and trend CAPA data to identify systemic issues requiring organizational attention
Lead cross-functional teams to address complex CAPA investigations and implementations
Administer the change control system, coordinating the initiation, execution, and completion of changes
Track timely completion of change control commitments and manage extension requests
Oversee the deviation management process, ensuring timely execution, closure and resolution
Establish, manage, and track quality system performance metrics to drive continuous improvement; Report to leadership, highlighting areas of concern and improvement opportunities
Conduct regular trend analysis across quality systems to identify proactive improvement initiatives
Prepare and present quality data for management review meetings
Collaborate with cross-functional teams to drive quality initiatives and resolve quality issues
Lead interactions between different departments to ensure quality requirements are understood and implemented
Support and participate in external audits including FDA, customers, and corporate audits
Build, develop, and retain a strong quality systems team through effective hiring, training, and motivation
Provide supervision, mentoring, and development to direct reports
Set goals and objectives for the quality systems team aligned with organizational objectives
Foster a culture of quality awareness, continuous improvement, and regulatory compliance