Full-Time

Associate Director

Quality Compliance

Confirmed live in the last 24 hours

Tarsus Pharamceuticals

Tarsus Pharamceuticals

201-500 employees

Biopharmaceuticals for eye and infectious diseases

Biotechnology
Healthcare

Compensation Overview

$142.5k - $199.5kAnnually

+ Bonus + Stock Equity

Expert

Irvine, CA, USA

Hybrid work environment with three onsite days and two remote days per week.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Data Analysis
Requirements
  • A minimum of 10 years’ relevant experience
  • A minimum of 7 years’ experience in Pharmaceutical Quality
  • Bachelor’s Degree from accredited university
  • Demonstrated understanding of regulatory requirements and expectations in Product Complaints
  • Analytical skills to interpret, predict and improve process and performance
  • Attention to detail
  • Strong verbal and written communication skills
  • Strong knowledge of Microsoft Office Systems
Responsibilities
  • Responsible for management and oversight of the end-to-end product complaint program from intake to complaint closure
  • Open Product Complaint Investigations
  • Liaise with Call Center staff for Product Complaint Intake
  • Chair 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 Management Review Presentations
  • Assist in any Recalls or Field Alerts
  • Perform Mock Recalls
  • Participate in Regulatory Inspections or Alliance Partner Audits as a SME
  • Drive improvement in QMS cycle times for Product Complaints
  • Author/Revise or Approve Controlled Documents
  • Understand the regulatory environment and work proactively to establish systems and procedures to ensure the product complaints are managed in accordance with company policies and government regulations
  • Implement effective Product Complaint processes, including investigation procedures, documentation systems, tools, metrics and measurable improvements
  • Ensure monitoring and appropriate escalation of Product Complaints, including expedited complaints
  • Support employee-related activities for Product Complaints function (i.e. ongoing employee training)
  • Establish effective relationships, cooperation and alignment of objectives within Quality and with internal partners
Tarsus Pharamceuticals

Tarsus Pharamceuticals

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Tarsus Pharmaceuticals develops treatments for diseases that lack effective solutions, focusing mainly on eye care and infectious diseases. Their key product, XDEMVY, is an FDA-approved eye drop solution used to treat Demodex Blepharitis, a condition affecting the eyelids. The company also has a pipeline of potential treatments for other conditions, including Lyme Disease Prevention and Rosacea. Tarsus differentiates itself from competitors by concentrating on specific medical needs and maintaining a strong commitment to ethical practices and compliance. Their goal is to improve patient outcomes by providing effective treatments for conditions that currently have limited options.

Company Stage

IPO

Total Funding

$58.4M

Headquarters

Irvine, California

Founded

2017

Growth & Insights
Headcount

6 month growth

5%

1 year growth

0%

2 year growth

6%
Simplify Jobs

Simplify's Take

What believers are saying

  • Growing awareness of Demodex blepharitis expands market for Tarsus's XDEMVY.
  • Telemedicine rise offers new marketing opportunities for Tarsus's products.
  • FDA's focus on unmet needs may expedite Tarsus's pipeline approvals.

What critics are saying

  • Increased competition in ophthalmic treatments challenges Tarsus's market position.
  • Potential clinical trial delays could affect Tarsus's product pipeline.
  • Supply chain constraints may hinder XDEMVY's production and distribution.

What makes Tarsus Pharamceuticals unique

  • Tarsus focuses on high unmet needs in ophthalmic and infectious diseases.
  • Their lead product, XDEMVY, is FDA-approved for Demodex blepharitis treatment.
  • Tarsus's pipeline includes innovative treatments for Lyme disease and Rosacea.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Paid Vacation

Hybrid Work Options

Professional Development Budget