QA Compliance Manager: Audits, CAPA & QMS

pciservices; San Diego (CA); On-site; USD 107,000 - 120,000; Full time

Job summary

PCI Pharma Services in San Diego seeks a Manager, Compliance to lead the QA Compliance team and ensure readiness for audits and regulatory inspections. You will drive risk management within the QMS and oversee CAPA investigations, deviations, and product quality impacts.

You will collaborate with SMEs to address audit observations, manage quality events, and strengthen client contracts. A strong regulatory background and leadership are essential for success in this role.

Qualifications

• Bachelor's degree in life sciences or engineering.
• 7+ years QA experience in regulated industry, biotech/pharma preferred.
• ≥3 years of leadership or supervisory experience.
• Experience with aseptic processing and barrier systems preferred.
• Knowledge of cGMP, FDA, ICH guidelines; familiarity with EU guidelines.
• Hands-on with QMS data management software (TrackWise, MasterControl, ETQ).
• Proficient data analysis and presentation tools (Visio, MS Office).

Responsibilities

• Lead QA Compliance team on internal audits and regulatory inspections.
• Oversee risk management and integration into the QMS.
• Direct audit, deviation and CAPA investigations.
• Manage quality events, observations, and product quality impacts.
• Improve department processes and contractual quality sections with clients.
• Maintain attendance, professional behavior, and alignment with PCI Pharma values.

Skills

Leadership

Audit management

QMS ownership

Regulatory knowledge

Education

Bachelor's degree in Life Sciences or Engineering

Tools

TrackWise

MasterControl

ETQ

Visio

Excel

Job description

PCI Pharma Services in San Diego seeks a Manager, Compliance to lead the QA Compliance team and ensure readiness for audits and regulatory inspections. You will drive risk management within the QMS and oversee CAPA investigations, deviations, and product quality impacts.

You will collaborate with SMEs to address audit observations, manage quality events, and strengthen client contracts. A strong regulatory background and leadership are essential for success in this role.