Manager II, Quality Compliance

Tarsus Pharmaceuticals•Irvine, CA

1d•$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). Let’s talk about some of the key responsibilities of the role: 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

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
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
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