Who is Tarsus? We are a biopharmaceutical company focused on the development and commercialization of therapeutic candidates designed to address diseases with high unmet need across therapeutic categories including eye care, dermatology, and infectious diseases.

Our lead product candidate, TP-03, is a novel therapeutic that has demonstrated positive results in two pivotal trials for the treatment of Demodex blepharitis (DB), a highly prevalent lid margin disease that affects approximately 25 million eye care patients in the U.S. TP-03 has the potential to be the first FDA-approved therapeutic and the standard of care for this disease. TP-03 is also being evaluated in a Phase 2a trial for the treatment of Meibomian Gland Disease.  We are also developing TP-04, a topical formulation, for the treatment of Rosacea, and TP-05, an oral, non-vaccine therapeutic for the prevention of Lyme disease. 

If you are looking for an opportunity to work alongside a diverse team with deep expertise, have a curious and driven mindset, and a passion for helping patients, then join our Tarsus community and help build our unique culture!

About the Role

The Manager, Quality Auditor is responsible for performance and participation in GMP, GLP, GXP supplier audits, internal audit program, external, customer and regulatory audit readiness. Responsible for continuous improvement of Quality Systems, creation and revision of procedures. This role has an ownership of the supplier qualification process, quality agreements and Supplier Management program.  

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

• Perform GMP, GLP and GXP audits of Tarsus external suppliers
• Perform internal audits at Tarsus for GMP and GXP
• Own the Supplier Qualification Program: receive and review requests for supplier qualification, and assign specific audit type, schedule new supplier audits and supplier re-qualification audits and coordinate issuance of audit agendas.
• For audits conducted, author audit reports and solicit feedback from the Operations, SMEs and Quality Teams. Distribute the completed audit report to the supplier and work with the supplier in responding to observations and reviewing and approving for acceptable corrective actions.  Review corrective action implementation evidence and issue an audit closure letter once all criteria are met.
• For audits performed by a different auditor, receive and review audit reports and solicit feedback from the Operations, SMEs and Quality Teams. Distribute the completed audit report to the supplier and work with the supplier in responding to observations and reviewing and approving for acceptable corrective actions.  Review corrective action implementation evidence and issue an audit closure letter once all criteria are met.
• Manage the Supplier module within the QMS to track activities for reporting in Management Review.
• Initiate CAPAs as appropriate to track audit responses.
• Initiate Quality Agreements with Suppliers and provide final drafts to Quality Management for review. Coordinate feedback and approval process for Quality Agreements.
• Assist with audit readiness, Government Agency Inspections and customer audits, manage backroom
• Continuous improvement of Quality Systems, including review, revision of existing SOPs and authoring new procedures
• Implement Supplier scorecard system and maintain it
• Review QMS records (deviations, CAPAs, change controls, complaints) for completes, accuracy and adherence to established procedures and current regulations
• Periodic review of issuance of unique identifiers in QMS
• Perform additional duties as assigned by department management

Factors for Success:

• Bachelor’s Degree or equivalent experience; Scientific Field Preferred
• Auditor Certification is preferred.
• 8 years experience in the areas of pharmaceutical Quality Assurance and Compliance:
• Regulatory Inspection Support
• Internal and External Audits
• Supplier Audits and Management
• Management Review
• Attention to detail
• Strong technical writing skills
• Strong computer skills in Word and Excel
• Previous job experience in a documentation environment
• Microsoft Office
• Sharepoint
• Other Quality Management Systems (Veeva, TrackWise, SAP, Oracle, DOT Compliance, Master Control, ComplianceWire and other LMS)

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. We provide a hybrid work environment.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our Associate Director, Quality Compliance
• Some travel may be required – up to 30%