Reference #: JR114684
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.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
Quality Management System Oversight
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
Corrective and Preventative Action (CAPA) Management
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
Change Control and Deviation Management
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
Quality Data Analysis and Reporting
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
Cross-Functional Collaboration and Leadership
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
Team Development and Management
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
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Required:
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
LI-LM1
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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company's EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.
