Lead QA Compliance Manager — Global Regulatory Readiness

PCI TRGR Penn Pharmaceutical Services Ltd; San Diego (CA); On-site; USD 107,000 - 120,000; Full time

Job summary

PCI Pharma Services in San Diego, CA is seeking a Manager, Compliance to lead a QA team ensuring audit readiness and regulatory compliance across FDA and global guidelines. You will drive risk management, CAPA, and vendor/customer audit programs while shaping QMS improvements.

Ideal candidate has a life sciences or engineering degree and at least 7 years in QA with leadership experience, and hands-on knowledge of TrackWise, MasterControl, and ETQ.

Qualifications

• Bachelor’s degree in Life Sciences or Engineering.
• Minimum 7 years of QA experience in a regulated industry.
• 3+ years of leadership or supervisory experience.
• Experience with GMP regulations and regulatory guidelines.

Responsibilities

• Lead QA Compliance team and manage internal audits and inspections.
• Oversee risk management and QMS process integration.
• Direct audit follow-ups, CAPA investigations and quality events.
• Maintain contractual quality sections with clients and vendors.
• Drive continuous improvement of QA processes and metrics.

Skills

Leadership

Quality Assurance

Audit management

Regulatory compliance

Risk assessment

Communication

Education

Bachelor's degree in Life Sciences or Engineering

Tools

TrackWise

MasterControl

ETQ

Job description

PCI Pharma Services in San Diego, CA is seeking a Manager, Compliance to lead a QA team ensuring audit readiness and regulatory compliance across FDA and global guidelines. You will drive risk management, CAPA, and vendor/customer audit programs while shaping QMS improvements.

Ideal candidate has a life sciences or engineering degree and at least 7 years in QA with leadership experience, and hands-on knowledge of TrackWise, MasterControl, and ETQ.