Manager II, Quality Compliance

the Tarsanet Internal Career Center • Irvine, CA

2d • $120,000 - $168,000 • Hybrid

About The Position

This position is responsible for supporting the Product Quality Complaint program and ensuring that all complaints are handled in accordance with GMPs and health authority requirements and expectations. This position will also be responsible for supporting Annual Product Reviews. In addition, the role includes supporting other QMS areas, when needed (i.e. Audits and inspections, Change Control, Document Control, CAPA).

Requirements

• Bachelor’s Degree in Scientific Field Preferred
• 8 years’ experience in the areas of pharmaceutical Quality Assurance and Compliance: Complaint Management Annual Product Review Document Management Regulatory Inspection Support Internal and External Audit Support Quality Management Review
• Attention to detail
• Strong knowledge of Microsoft Office Systems
• Knowledge of Other Quality Management Systems (Veeva, TrackWise, SAP, Oracle, DOT Compliance, Master Control, ComplianceWire and other LMS)
• Decision Making - Demonstrates strong decision-making by applying structured analysis to complex challenges, balancing competing priorities and long-term impacts while engaging stakeholders and driving solutions aligned with organizational goals.
• Collaboration and Team Building - Promotes collaboration by aligning diverse teams around shared goals, fostering healthy debate to advance outcomes, and building strong networks that strengthen organizational effectiveness and cross-team learning.
• Outcome Driven - Demonstrates strong outcomes focus by aligning teams around shared priorities, proactively addressing risks and dependencies, and driving cross-functional accountability to sustain progress and deliver results.

Responsibilities

• Support of the product complaint program, from intake to closure, including:
• Open Product Complaint Investigations
• Liaise with Call Center staff for Product Complaint Intake
• Follow-up directly with complainants, when necessary
• Participate in Weekly Product Complaint Meetings
• Prepare Response Letters to Complainants
• Review proposed Product Complaint investigations and close the Complaints
• Contribute Product Complaint Data to Annual Product Reviews
• Prepare monthly complaint metrics and Management Review Presentations
• Support Regulatory Inspections or Alliance Partner Audits, as required
• Author/Revise or Approve Controlled Documents
• Understand the regulatory environment and work proactively to evolve systems and procedures to ensure the product complaints are managed in accordance with company policies and government regulations.
• Ensure monitoring and appropriate escalation of Product Complaints, including expedited complaints.
• Support effective relationships, cooperation and alignment of objectives within Quality and with internal partners
• Assemble Annual Product Reviews and:
• Ensure contributing departments/partners deliver data timely
• Prepare product complaint data/metrics for the APR
• Ensure on time delivery of completed report
• Assist in any Recalls or Field Alerts
• Assist in performing Mock Recalls
• Support other Quality Management Systems, as required: Document Control, Change Control and CAPA systems
• Perform additional duties as assigned by department management

Benefits

• onsite gym
• pool
• snacks
• drinks
• occasional catered meals
• hybrid work environment
• health, dental and vision insurance benefits
• generous paid time off, including vacation, holidays, and personal days

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 101-250 employees