Supervisor, Clinical Quality D

PCI Pharma Services•Rockford, IL

18d•$62,960 - $70,830

About The Position

The Clinical Quality Supervisor oversees the daily operations of the Clinical Quality Department, including In-Process/Finished Goods Inspection and, when required, Receiving Inspection. The role resolves quality issues and deviations, trains and mentors staff, and maintains high quality standards in compliance with current Good Manufacturing Practices, company Standard Operating Procedures, and customer requirements. The supervisor plans resources and workloads across inspection teams, directs Quality Operations activities, develops direct reports, and leads quality improvement and documentation-compliance efforts. The role makes risk-based decisions affecting product quality, collaborates with Operations and Quality leadership, manages quality events and investigations in the QMS, and reports metrics to management. The position may require overtime and weekend work.

Requirements

Associate's degree in a related field and/or 1–3 years of related experience and/or training.
Basic mathematical skills.
Intermediate computer skills, including the ability to perform more complex computer tasks and knowledge of various computer programs.
Full professional proficiency in speaking, reading, and writing for professional needs.
Very high reasoning ability, including defining problems, collecting data, establishing facts, and drawing valid conclusions.
Ability to interpret a wide variety of technical instructions in mathematical or diagram form and work with several abstract and concrete variables.
High standard of report writing.

Nice To Haves

Ability to identify and resolve problems in a timely manner.
Willingness to make decisions.
Ability to conduct oneself professionally.
Excellent time management skills.

Responsibilities

Supervise resource allocation and workload planning for In-Process/Finished Goods Inspection, Distribution and Returns Inspection, and Clinical Quality Label Room Inspection teams.
Direct Quality Operations activities and supervise quality inspectors, coaching them toward performance goals and PCI standards.
Oversee quality improvement processes across Clinical Quality Inspection functions, including training, mentoring, and equitable development of direct reports.
Resolve quality issues across Clinical departments using applicable SOPs and written guidance, making risk-based decisions that balance quality needs with operational requirements.
Organize and direct department and team meetings, including Clinical Batch Record improvement meetings.
Generate and present Quality Operations metrics and key performance indicators to senior PCI management and internal teams as needed.
Review and interpret customer standards, procedures, and specifications for records, forms, and Batch Records, including SOPs, work instructions, and job aids.
Review and approve internal and customer-based Batch Record specifications required for production packaging.
Provide daily feedback and collaborate with Operations on quality- and business-related matters.
Maintain internal and external Right First Time documentation compliance across functional areas, and host weekly meetings with Quality and Operations leadership to discuss errors and preventive measures.
Study and standardize departmental work practices to improve quality and ensure team compliance.
Promote continuity between quality shifts by communicating relevant quality events, staffing issues, and management messaging.
Initiate Quality Operations events and document them in the QMS; determine root causes and corrective actions, and assist with investigation responses to the Senior Supervisor or Manager.
Gather information and enter Non-Conforming Material Reports (NONCs) in the QMS.
Communicate employee disciplinary issues to HR and Quality Management and seek recommendations before counseling employees or documenting disciplinary actions.
Maintain and monitor departmental quality testing equipment as needed.