Supervisor, Quality Systems

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Summary:

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. This 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 the implementation and continuous improvement of QMS processes; and ensuring departmental priorities are executed in accordance with site procedures and regulatory expectations.

This position also supports site Quality KPI reporting by monitoring data accuracy, identifying trends and risks, and escalating performance concerns to Quality leadership.

Shift: 1st

8AM-5P M

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.

• 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, which may include 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 the 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 the development of appropriate 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.
• Perform additional duties as required to support site Quality and business objectives.

Leadership Expectations

• Provide clear direction and maintain accountability for daily execution.
• Communicate priorities, risks, and performance concerns promptly.
• Apply sound judgment when assessing quality and compliance issues.
• Develop team capability through coaching, cross-training, and effective delegation.
• Foster strong cross-functional partnerships and a proactive quality culture.
• Ensure timely escalation and resolution of issues affecting compliance, customers, or site objectives.
• Drive timely decision-making, escalation, and resolution of significant quality concerns.
• Establish sustainable processes rather than short-term corrective actions.
• Build strong cross-functional and client relationships.
• Promote a proactive, inspection-ready Quality culture.
• Coach and develop team members while maintaining high standards for execution and compliance.
• Regular and reliable on-site attendance on a full-time basis.
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Embodies PCI Pharma Services’ cultural values and aligns daily actions with department goals and company culture.

Qualifications: The requirements listed below are representative of the education, experience, 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.

• High School diploma or equivalent required. Bachelor's degree in Life Sciences or a related field preferred; equivalent combination of education and/or relevant work experience will be considered.
• 5-7+ years of experience in Quality Assurance, Quality Systems, pharmaceutical manufacturing, biotechnology, or a related regulated industry.
• Previous experience as a supervisor, team lead, project lead, or senior individual contributor with responsibility for coordinating work and supporting employee development preferred.
• 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.
• Experience supporting sterile, biologic, pharmaceutical, or contract manufacturing operations preferred.
• 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.
• Proficiency with electronic quality management systems and quality-data reporting tools preferred.

Success Measures

• Timely, accurate, and compliant execution of assigned Quality Systems activities.
• Consistent delivery of complete, inspection-ready records with reduced rework and improved right-first-time performance.
• Effective prioritization of team workload to meet site, client, and regulatory commitments.
• Improved performance against key QMS metrics, including record aging, overdue actions, closure timelines, and review-cycle efficiency.
• Early identification and escalation of compliance risks, resource constraints, and operational barriers.
• Clear accountability across the team through effective delegation, follow-up, coaching, and performance management.
• Measurable growth in employee capability through training, cross-functional development, and succession planning.
• Strong coordination with Manufacturing, Quality Control, Validation, Engineering, and other functional partners.
• Effective support of client audits, regulatory inspections, remediation activities, and inspection-readiness efforts.
• Successful implementation of process improvements that strengthen compliance, efficiency, transparency, and team performance.
• Accurate and timely Quality KPI reporting, with clear communication of trends, risks, and corrective actions to leadership.
• Development of a reliable and engaged team capable of independently managing routine Quality Systems responsibilities.

The hiring rate for this position is $76,00 - 95,000 annually plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan..

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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.