Supervisor, Quality Systems

PCI Pharma Services•San Diego, CA

3d•Onsite

About The Position

The Supervisor, Quality Systems supports execution and maintenance of the Quality Management System across PCI’s 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, coordinating timely review, approval, and completion of quality records and supporting QMS implementation and continuous improvement. The role also supports Quality KPI reporting by monitoring data accuracy, identifying trends and risks, and escalating performance concerns to Quality leadership. The Supervisor provides direction and accountability for daily execution, communicates priorities and risks, and develops team capability through coaching, cross-training, delegation, and performance feedback. The role partners with site functions and clients to resolve quality-system issues, support GMP operations, audits, regulatory inspections, and inspection-readiness activities, and foster a proactive quality culture. Regular and reliable on-site attendance on a full-time basis is required. The position requires a high school diploma or equivalent. A bachelor’s degree in Life Sciences or a related field is preferred, though an equivalent combination of education and relevant work experience will be considered. Candidates should have 5–7+ years of relevant experience in Quality Assurance, Quality Systems, pharmaceutical manufacturing, biotechnology, or a related regulated industry. The hiring rate is $76,000–$95,000 annually, with eligibility for an annual performance bonus. PCI offers full-time employees paid time off, health insurance including dental and vision, a flexible spending account, and a 401(k) plan.

Requirements

High school diploma or equivalent required.
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; equivalent combinations of education and relevant work experience will be considered.
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 review, approval, tracking, and closure of QMS records, potentially 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 in developing 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.
Use sound judgment in assessing quality and compliance issues and ensure timely escalation and resolution of significant concerns.
Develop team capability through coaching, cross-training, effective delegation, and employee development.
Establish sustainable processes and foster strong cross-functional and client relationships.
Perform additional duties as required to support site Quality and business objectives.
Maintain regular and reliable on-site attendance on a full-time basis and exhibit professional behavior consistent with company policies and practices.