QA Compliance Leader - Audit & Risk Management

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

Benefits offered by this job

Competitive benefits package

Paid time off

Health, dental, vision insurance

Flexible spending account

Job summary

PCI Pharma Services is seeking a Manager, Compliance to lead a QA Compliance team responsible for internal audits and external inspections across clinical and commercial manufacturing facilities. You will oversee risk assessment, CAPA investigations, and ensure alignment with FDA and international regulations within the QMS framework.

The role requires a Bachelor’s degree in Life Sciences or Engineering, 7+ years QA experience, and 3+ years of leadership.

Qualifications

• Bachelor’s degree in Life Sciences or Engineering discipline.
• Minimum of 7 years of QA experience in a regulated industry; biotech/pharma preferred.
• Minimum of 3 years of leadership or supervisory experience.
• Experience with aseptic processing; RABS and isolators preferred.
• Working knowledge of cGMPs, FDA regulations, ICH Guidelines; European guidelines knowledge.

Responsibilities

• Manages QA Compliance team activities including internal audits and external inspections.
• Develops technical acumen and decision-making in reports.
• Oversees the risk management program and integration into the QMS.
• Leads audit, deviation and CAPA investigations.
• Oversees audit observations, quality events and adverse events impacts.
• Manages quality event trend reports and metrics; drives process improvements.

Skills

QA compliance

leadership

regulatory requirements

audits

QMS

risk management

data analysis

communication

vendor audits

Education

Bachelor's degree in Life Sciences or Engineering

Tools

TrackWise

MasterControl

ETQ

Visio

Excel

PowerPoint

Job description

PCI Pharma Services is seeking a Manager, Compliance to lead a QA Compliance team responsible for internal audits and external inspections across clinical and commercial manufacturing facilities. You will oversee risk assessment, CAPA investigations, and ensure alignment with FDA and international regulations within the QMS framework.

The role requires a Bachelor’s degree in Life Sciences or Engineering, 7+ years QA experience, and 3+ years of leadership.