Supervisor, Quality Systems

PCI Pharma Services•San Diego, CA

5d•$76,000 - $95,000•Onsite

About The Position

The Supervisor, Quality Systems supports the execution and maintenance of the Quality Management System across the San Diego D&M sites in support of GMP manufacturing operations. The role helps ensure site quality systems are effectively implemented, compliant, inspection-ready, and aligned with applicable U.S. and international regulatory requirements. The Supervisor provides day-to-day oversight of assigned Quality Systems activities, personnel, and workflows. Responsibilities include coordinating the review, approval, and timely completion of quality records; supporting implementation and continuous improvement of QMS processes; and ensuring departmental priorities are executed in accordance with site procedures and regulatory expectations. The position also supports site Quality KPI reporting by monitoring data accuracy, identifying trends and risks, and escalating performance concerns to Quality leadership. The position is on-site, full-time, on the first shift from 8:00 a.m. to 5:00 p.m. It requires regular and reliable on-site attendance. The stated hiring range is $76,000–$95,000 annually, with eligibility for an annual performance bonus.

Requirements

High school diploma or equivalent required; equivalent combinations of education and/or relevant work experience may be considered.
5–7+ years of experience in Quality Assurance, Quality Systems, pharmaceutical manufacturing, biotechnology, or a related regulated industry.
Demonstrated knowledge of GMP regulations and quality-system requirements, including applicable FDA, EU, and international regulatory expectations.
Experience managing or supporting deviations, investigations, CAPAs, change controls, document control, training, audits, inspections, and quality metrics.
Demonstrated experience interacting with clients, regulatory agencies, and internal or external auditors.
Strong analytical, organizational, problem-solving, and decision-making skills.
Ability to manage multiple priorities in a fast-paced, complex manufacturing environment.
Strong written, verbal, presentation, and stakeholder-management skills.
Regular and reliable on-site attendance on a full-time basis.

Nice To Haves

Bachelor's degree in Life Sciences or a related field.
Previous experience as a supervisor, team lead, project lead, or senior individual contributor with responsibility for coordinating work and supporting employee development.
Experience supporting sterile, biologic, pharmaceutical, or contract manufacturing operations.
Proficiency with electronic quality management systems and quality-data reporting tools.

Responsibilities

Supervise the daily execution of assigned Quality Systems processes and activities.
Ensure quality records are complete, accurate, timely, and maintained in an inspection-ready state.
Coordinate the review, approval, tracking, and closure of QMS records, including deviations, investigations, CAPAs, change controls, quality events, document control, and training activities.
Assign work, establish priorities, monitor progress, and escalate risks or barriers that may affect compliance or business timelines.
Provide coaching, technical guidance, and performance feedback to Quality Systems team members.
Support implementation, maintenance, and continuous improvement of site QMS procedures and programs.
Partner with Manufacturing, Quality Control, Validation, Engineering, and other site functions to resolve quality-system issues and support GMP operations.
Support Quality KPI data collection, verification, reporting, and trend analysis.
Identify overdue records, recurring issues, and adverse trends, and assist with recovery or improvement plans.
Support client requests, audits, regulatory inspections, and inspection-readiness activities.
Serve as a Quality Systems subject-matter resource for assigned processes.
Promote accountability, compliance, collaboration, and continuous improvement within the team.
Provide clear direction and maintain accountability for daily execution; communicate priorities, risks, and performance concerns promptly.
Apply sound judgment to quality and compliance issues, develop team capability through coaching, cross-training, and delegation, and foster cross-functional partnerships and a proactive quality culture.
Ensure timely escalation and resolution of issues affecting compliance, customers, or site objectives; establish sustainable processes and build strong cross-functional and client relationships.
Exhibit professional behavior with internal and external business associates, align daily actions with department goals and company culture, and perform additional duties as required to support site Quality and business objectives.