Quality Systems Manager

Quality Systems Manager

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

Change Control and Deviation Management

Quality Data Analysis and Reporting

Cross-Functional Collaboration and Leadership

Team Development and Management

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 :

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.