About the Role:
This position is responsible for developing, implementing and improving the Product Complaint program, and ensuring that these responsibilities are maintained in accordance with GMPs and health authority requirements and expectations. This position will be a subject-matter expert for regulatory inspections or alliance partner audits.
Let’s talk about some of the key responsibilities of the role:
- Responsible for management and oversight of the end-to-end product complaint program from intake to complaint closure, including:
- 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 Response Letters to Complainants
- 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
Factors for Success:
- 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
- Charts and Graphs
A Few Other Details Worth Mentioning:
- This position reports to the Director, Quality Compliance
- Travel anticipated to be minimal, estimated to be less than 10%
- This position will be based in our beautiful Irvine office with a courtyard, snacks, drinks and occasional catered meals. We provide a hybrid work environment with three onsite days and two remote days per week.
At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $142,500 - $199,500 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://alliantbenefits.cld.bz/25tarsusbenesnap.
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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.
What We Do
Tarsus is a late clinical-stage biopharmaceutical company that applies proven science and new technology to revolutionize treatment for patients with unmet needs.
