Work at Tarsus

Quality

Sr Manager, Clinical QA


Reporting to the Sr. Director of Quality Assurance, the Sr. Manager of Clinical Quality Assurance is responsible to have appropriate oversight of CROs, GLP Labs and the Tarsus Clinical Program. This position is responsible for GCP, GLP and GPVG supplier audits, quality agreements, attending project meetings and review and approval of protocols and reports.  This position is also responsible for inspection readiness of the company, oversight of Trial Master Files (TMF) and Quality Oversight per ICH Guidance E6 R2.

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

  • Perform GCP/GLP/GPVG audits as needed and author reports for audits performed
  • Review audit responses and review implementation evidence
  • Author Quality Agreements with CROs and GLP Labs
  • Support the implementation and revision of Clinical Affairs/Clinical Operations SOPs/procedures
  • Implementation and revision of Clinical Quality SOPs/procedures
  • Assure Quality Oversight of the Clinical Program in Accordance with Good Clinical Practice Guidance E6 R2
  • Support inspection readiness for the company, no ensure its contractors and vendors are prepared for FDA and other Health Authority GCP/GPVP/GLP inspections
  • Act as subject matter expert for clinical regulatory inspections
  • Provide day-to-day Quality support and oversight of Clinical Studies including participating in the Clinical Study Team meetings, providing sound and timely compliance advise, and reviewing essential documents per the agreed timeline
  • Perform review of clinical protocols, protocol amendments and Clinical Study Reports (CSRs)
  • Support implementation of eTMF; oversight of Trial Master Files
  • Perform/Review Risk Assessments
  • Provide support to Clinical Operations for clinical planning, start-up, execution and close-out

Factors for Success: 

  • 12 years experience in the Pharmaceutical Industry
  • 7 years experience in Pharmaceutical Clinical Quality Assurance
  • Bachelor’s Degree from accredited university
  • Extensive knowledge of ICH GCP E6 R2 with experience in Quality Oversight and Risk Management, global clinical regulations and clinical development
  • Experience with investigations using root cause analysis, CAPA and CAPA effectiveness
  • Attention to detail
  • Strong computer skills

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, occasional catered meals, and pet-days.
  • This position reports directly to the Sr. Director, Quality
  • Some travel may be required – up to 15%

Equal Employment Opportunity Employer

At Tarsus Pharmaceuticals, we value bringing together individuals from diverse backgrounds to drive better results for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. Equal Employment Opportunity is the law, and you can find more information here. If you are an applicant and would like to request an accommodation, please email careers@tarsusrx.com.

Quality

Sr Manager, Clinical QA


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