QA Compliance Manager: Audits, Risk & Regulatory Readiness

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

Benefits offered by this job

Health insurance (dental & vision)

401(k) plan

Paid time off

Flexible spending account

Job summary

PCI Pharma Services seeks a Manager, Compliance to lead the QA Compliance team and ensure audit readiness across clinical and commercial facilities. You will manage audits, CAPA investigations, and QMS activities in line with FDA, ICH and cGMP requirements.

The role emphasizes risk management, contract quality, and collaboration with manufacturing and other stakeholders to sustain compliance and drive continual improvements.

Qualifications

• Bachelor’s degree in Life Sciences or Engineering; equivalent also acceptable.
• 7+ years QA experience in regulated industry; biotech/pharma preferred.
• 3+ years of leadership or supervisory experience.
• Experience with aseptic processing; RABS/isolators preferred.
• Knowledge of cGMP, FDA regs, ICH in drug/device; EU cGMP familiarity.

Responsibilities

• Manages QA Compliance team activities for internal audits and external inspections, plus vendor and customer audits.
• Develops technical acumen and leadership in direct reports.
• Oversees risk management integration into QMS and coordination with manufacturing.
• Leads complex audit, deviation and CAPA investigations.
• Oversees process impact of audit findings and quality events.
• Manages quality event trends and metrics to monitor key attributes.
• Drives improvements to QMS and manufacturing processes for compliance.
• Develops quality sections of client contracts.

Skills

QA Compliance

Leadership

Regulatory Knowledge

Audits & CAPA

QMS

Risk Management

Education

Bachelor's degree in Life Sciences or Engineering

Tools

TrackWise

MasterControl

ETQ

Job description

PCI Pharma Services seeks a Manager, Compliance to lead the QA Compliance team and ensure audit readiness across clinical and commercial facilities. You will manage audits, CAPA investigations, and QMS activities in line with FDA, ICH and cGMP requirements.

The role emphasizes risk management, contract quality, and collaboration with manufacturing and other stakeholders to sustain compliance and drive continual improvements.