PCI Pharma Services · 8 hours ago
Sr. Compliance Associate I
San Diego, CA
Full-time
Onsite
Senior Level
$45.86/hr - $51.58/hr
6+ years expPCI Pharma Services is a company focused on life changing therapies with a global impact. The Sr. Compliance Associate I will lead customer and regulatory audits, assist in internal audits, and support the vendor management program while ensuring compliance with quality management systems.
BiotechnologyMedical DeviceHealthcarePharmaceuticalLife ScienceLogisticsHealth CarePackaging Services
Responsibilities
Leads customer audits, collaborates with Subject Matter Experts to address audit findings, and tracks the customer audit program for continuous improvement
Supports vendor management program, occasionally conducts on-site and paper audits, and establishes Quality Agreements
Supports the execution of internal audit program
Supports risk management program
Supports the continuous improvement of the Quality Management System
Reviews and approves quality management system standard operating procedures (SOPs)
Reviews and approves deviation reports and CAPAs related to quality systems
Generates quality system metrics for management review meetings
Trains team members on conducting internal and external audits
Regular and reliable attendance on a full time basis [or in accordance with posted schedule]
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
Qualification
Required
Bachelor's Degree in a Life Sciences discipline or equivalent relevant experience required
Minimum of 6 years of relevant QA experience in a regulated industry
At least two (2) years relevant experience of manufacturing in a GMP environment or Drug Product Manufacturing Preferred
Advanced-level understanding of regulatory requirements related to aseptic drug product manufacturing and testing
Knowledge and hands on experience with QMS data management software such as ACE, Track Wise, Master Control, ETQ, etc
Highly effective in collaborating with internal and external customers, leading improvement projects, and training team members on internal and external auditing
Detail-oriented with strong organizational skills
Benefits
Paid time off
Health insurance coverage (including dental and vision)
A flexible spending account
A 401(k) plan
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Bain Capital,Kohlberg & Company
2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase