Director, Quality Compliance

About the Role:

This position is responsible for overseeing the internal GxP quality management system (QMS), learning management system (LMS) and associated quality policies, procedures and standards to support Tarsus’ drug development and commercialization activities. In addition, this position is responsible for directly supporting the organization, coordination and management of regulatory agency audits by external parties and to present all QMS related topics to inspectors/auditors.

As the Head of Quality Compliance, this position will provide proactive leadership and direction, enable growth and development of Quality Systems/Quality Compliance staff, and promote cross-functional collaboration with Quality business partners, both internal and external. 

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

• Maintain and further develop the Quality Management System (QMS), the GxP Learning Management System (LMS) and other GxP related systems and provide updates to Quality Management
• Ensure the Quality Compliance team, along with internal business partners, maintain a state of GxP compliance and inspection readiness
• Support the Head of Quality in developing and implementing the overall Quality strategy
• Manage a team responsible for maintaining GxP Quality controlled documents and systems, and coordinating GxP compliance training
• Provide oversight of the GxP computer system validation program (i.e. assessments, validation and change control, etc.) to ensure compliance with GxP regulations
• Directly support the organization, coordination and management of Internal Audits, Regulatory Agency inspections and audits by external business partners
• Develop, implement and support continuous process improvements across multiple GxP disciplines
• Support the management of field alert and recall processes and communications
• Support external GxP qualification and audit activities
• Responsible for overseeing activities associated with the product complaint process
• Responsible for Quality Management Review program
• Oversight of Design Control and associated Risk Management for Combination Products
• Perform other duties as assigned
• Drive improvement in QMS cycle times, including: deviations, change control, product complaints, CAPAs

Factors for Success:

• Bachelors Degree in Life Sciences or a related field and 12 years experience in the Pharmaceutical industry working in a regulated environment
• A minimum of 7 years' experience in Pharmaceutical/Device Quality
• Minimum 5 years’ experience managing and motivating a team
• Established leadership track record with evidence of excellent people management experience, problem solving, collaboration, cross functional leadership and effective communication skills
• Excellent attention to detail
• Strong computer skills including knowledge of Microsoft Office Systems
  • Proven expertise using excel and PowerPoint to analyze and present data

A Few Other Details Worth Mentioning: 

• This position reports directly to the VP of Quality
• Travel will be required, approximately 15%
• 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.

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $174,000 - $243,600 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/tarsus2024BenSnapshot.

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