Sr. Manager Quality Compliance - Tarsus Biopharmaceutical, Irvine, CA

Sr. Manager Quality Compliance - Tarsus

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Tarsus is looking for inspired individuals who are interested in growing their career while helping us advance our mission to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care.

Who is Tarsus? We are a late clinical-stage biopharmaceutical company focused on the development and commercialization of therapeutic candidates to address diseases with high unmet need.

Tarsus is developing a pipeline of medicines and our lead product candidate, TP-03, is in a Phase 3 and second pivotal trial for the treatment of Demodex blepharitis (DB). TP-03 has the potential to be the first FDA-approved therapeutic and the standard of care for the treatment of Demodex blepharitis, a common lid margin disease that may affect up to 25 million people in the U.S. Significant commercial strategic planning is currently underway for TP-03. We are also developing TP-03 for the treatment of Meibomian Gland Disease, TP-04 for the treatment of Rosacea, and TP-05, an oral, non-vaccine therapeutic for the prevention of Lyme disease. TP-03 and TP-04 are expected to be in Phase 2a studies in 2022, and TP-05 is currently being studied in a Phase 1b clinical trial.

Join us in advancing our pipeline to address a number of diseases across therapeutic categories including eye care, dermatology, and other diseases with high unmet needs.

Let’s talk about some of the key responsibilities of the role:

This position is responsible for oversight of Vendor Management, supplier audits, internal audits, Quality Management System (QMS), Computer System Validation, Document Control, Training Administration, and Records Management. This position is responsible for authoring/revising quality agreements, controlled documents and preparation of management review. This position will have oversight of GxP Computer System Validation and oversight of design controls and risk assessments for combination products. This position will participate in any field alerts or recalls, regulatory inspections or customer audits.

  • Oversight of Vendor Management
  • Oversight of External Audits
  • Oversight of Document Control
  • Oversight of Training Administration
  • Oversight of Records Management
  • Oversight of Internal Audits
  • Oversight of Quality Management System (QMS)
  • Oversight of GxP Computer System Validation
  • Author/Revise Quality Agreements
  • Author/Revise or Approve Controlled Documents
  • Review/Approve Design Controls and Risk Assessments for Combination Products
  • Perform External Supplier Audits or perform Internal Audits as needed
  • Prepare Management Review
  • Assist in any Recalls or Field Alerts
  • Participate in Regulatory Inspections or Customer Audits
  • Participate in Due Diligence Processes
  • Drive improvement in QMS cycle times:
    • Deviations
    • Change Control
    • Product Complaints
    • CAPAs

Factors for Success:

  • 12 years experience in the Pharmaceutical/Medical Device Industries
  • 7 years experience in Pharmaceutical/Device Quality
  • Previous experience Managing employees in Quality
  • Bachelor’s Degree from accredited university
  • Attention to detail
  • Strong computer skills
  • Knowledge of Microsoft Office Systems
    • Charts and Graphs

A Few Other Details Worth Mentioning:

  • The position will be based in our beautiful Irvine office, complete with a courtyard, table tennis, snacks and drinks, and occasional catered meals
  • This position reports directly to the Head of Quality
  • Some travel may be required – up to 15%