Manager II, Quality Assurance (Commercial)

AI overview

Lead quality assurance efforts and ensure compliance through comprehensive review processes and engagement with manufacturing partners, while maintaining high attention to detail.

Reporting to the Associate Director, Quality Assurance, the Manager II, Quality Assurance, is responsible for the review and processing of manufacturing Deviations and Laboratory OOS, and review of manufacturing-related Change Controls within Tarsus’ established QMS system. This role will also be responsible for authoring Annual Product Reviews, analyzing and trending analytical data, approval of Certificates of Analysis, manufacturing batch record review and product disposition.

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

  • Review/Approve Vendor Change Controls
  • Review/Approve vendor documents including Master Batch Records/Master Packaging Records
  • Review Specifications
  • Review/Approve Deviations/OOS
  • Analyze and trend data
  • Author Annual Product Reviews
  • Author/Revise relevant Quality Assurance Procedures
  • Review new proposed master manufacturing records and manufacturing-related process validation protocols
  • Review/Approve Test Record Review Form and Certificate of Analysis
  • Review/Approve executed manufacturing batch records and packaging batch records
  • Review/Approve/Complete Batch Record Review Form (Batch Disposition)
  • Complete Final Product Disposition Form and Certificate of Compliance
  • Participate in internal Operations
  • Participate in Meetings/ discussions with Tarsus’ manufacturing partners and testing laboratories

Factors for Success:

  • Bachelor’s Degree preferred, plus 8+ years’ experience in the Pharmaceutical Industry
  • 5+ years experience in Pharmaceutical Quality Assurance
  • Strong attention to detail
  • Proficient technical skills across multiple platforms
  • Strong knowledge of Microsoft Office Systems
    • Charts and Graphs
  • ASQ Certification Preferred

A Few Other Details Worth Mentioning:

  • The position is hybrid and will be based in our beautiful Irvine office three days per week, complete with a courtyard, snacks, drinks, occasional catered meals, and pet-days.

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $120,000 - $168,000 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

#LI-Hybrid

Tarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Perks & Benefits Extracted with AI

  • Free Meals & Snacks: complete with a courtyard, snacks, drinks, occasional catered meals, and pet-days.
  • Health Insurance: Our benefits include health, dental and vision insurance benefits to ensure your well-being.
  • Paid Time Off: generous paid time off, including vacation, holidays, and personal days

At Tarsus, we are looking for inspired individuals who are motivated to grow professionally, while building a best-in-class pharmaceutical company with a differentiated approach. Join us in advancing our mission to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients.   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 and infectious diseases.   We are advancing our pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care and infectious disease prevention. XDEMVY® (lotilaner ophthalmic solution) 0.25% is FDA-approved in the United States for the treatment of Demodex blepharitis. In addition, we are developing TP-04 for the potential treatment of ocular rosacea and TP-05, an oral tablet for the prevention of Lyme disease. TP-05 is currently being studied in a Phase 2a clinical trial and TP-04 is scheduled to begin a Phase 2 clinical trial in 2025 to evaluate safety, tolerability and proof of activity.   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!

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Salary
$120,000 – $168,000 per year
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