"Alerted.org

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

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

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._

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled