Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.
At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do.
We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.
At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.
The Director, Quality Operations is responsible for overseeing Quality Assurance (QA), Quality Agreements, Inspection Readiness, QA batch review of Quality Control (QC), QA oversight of Quality Control activities, QC Labs, Contract Laboratory Organizations (CLOs), and compliance support for the quality systems at Travere Therapeutics, Inc. and any of its subsidiaries. In addition, this position ensures the following are completed: Quality Agreements, Inspection Readiness, overall compliance to internal procedures and regulatory requirements, Batch Review, Batch Release, Internal Audits, and continual process improvement for Quality Management Systems.
Leads the efforts for Quality Assurance (QA) Batch Review, Batch Release, and QA oversight of Quality Control Activities, QC Labs, and Contract Laboratory Organizations (CLOs).
Leads efforts to complete the QA approval of QC activities related to intermediates and final products.
Collaborates closely with Technical Operations Personnel responsible for Stability, Analytical Development, Method Transfer to provide QA input, support, and oversight.
Leads efforts for QA Oversight of QC Labs and Contract Laboratory Organizations (CLOs) starting with Phase 2 Clinical Trials to approved products, and in all situations where GMP Batches are required.
Leads the efforts for GMP Inspection Readiness for assigned SOPs, CAPAs, Deviations, Investigations, Product Complaints, Audit Responses, Change Controls, Training, Mock Inspection Action Items, and ensures group and department completion on schedule.
Lead SME for Quality Systems and a Power User for the AuditUtopia® software system.
Leads and provides support for all products for clinical development and commercial production including the following types of products: Oral Drugs, Biologics, Injectables, Parenteral Drugs, Combination Products.
Leads, implements, updates, manages the Quality Agreements with suppliers, CMOs, CLOs, Contract Warehouses and Distributors.
Leads, manages, and provides daily oversight of the quality systems including, CAPAs, Deviations, Investigations, Batch Record Review, Batch Release, Change Control.
Leads the team on GMP-compliant Documentation Management.
Leads and completes action items for Supplier Management, Supplier Qualification, Supplier Oversight, and Supplier Audits for assigned suppler and products.
Leads efforts, provides guidance and assistance with the development and review of new Quality Agreements.
Leads GMP efforts for group, provides guidance and assistance to the team during inspections, audits, and due diligence activities.
Manages the Internal Audit Program.
Leads semi-annual Management Reviews and Annual Product Reviews.
Assists in and conducts vendor/contractor qualification audits.
Pro-actively and effectively communicates within Quality Assurance and R&D regarding the developments, progress, activities and results for assigned responsibilities.
Ability to independently manage vendors and third-party providers and effectively resolve issues escalated from the project teams.
Pro-actively identifies and mitigates key cross-functional and vendor issues independently with limited need to escalate.
Prepares and delivers status updates to senior and management as needed.
Exhibits leadership behaviors by setting high standards and goals for oneself and direct reports.
Contributes to the development of the Quality Assurance function by initiating and driving positive change with the oversight of new initiatives, systems or directives for ongoing process improvement and implementation of best practices.
Leads and implements action items to complete Root Cause Analysis (RCA) methods, to develop Corrective Action (CA) Plans, Preventive Action (PA) Plans, and objective evidence of completion.
Lead efforts to complete document Effectiveness Checks for CAPAs, Deviations, and Change Controls.
Provides support to all Validation efforts, projects, and action items including validations for: Process; Facilities, Utilities, Equipment (FUE); Shipping; Cleaning; and Analytical Method.
Bachelor’s degree in related Life Sciences discipline such as Biology, Chemistry, Chemical Engineering, Biochemical Engineering, Biochemistry, Biomedical Sciences. Equivalent combination of education and applicable job experience may be considered.
Minimum of 10 years of experience working in an FDA regulated industry in Quality Assurance (QA) or a related field, with a focus on QA Batch Review, QA oversight of Quality Operations, Batch Release, Internal Audits, CAPAs, Root Cause Analysis, Deviations
Minimum of 5 years of experience leading QA oversight of Quality Control, QC Labs, and Contract Laboratory Organizations (CLOs).
10 years of experience needed in any of the following industries or a combination of industries: Biotechnology, Pharmaceutical, Combination Products, Biologics.
Quality Assurance (QA) experience with Manufacturing, Operations, Logistics, Laboratories, CMOs, CDMOs, CLOs, Distributors, Warehouses is preferred.
The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork.
Experience with Oral Solid Dosage Forms, Injectables, Biologics, Medical Devices, and Combination Products, and Inspection Readiness is preferred.
Broad knowledge of cGMPs (CFR/ICH) and applicable international regulations and guidelines.
Preference for candidates familiar and experienced with electronic QMS such as Veeva or similar, and familiar with Audit Utopia.
Strong professional experience in a similar role within the pharmaceutical industry, preferably small molecule pharmaceuticals, biologics, or combination products.
Well organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
Previous line management experience with the ability to effectively manage performance, engage team members, provide coaching, implement improvements, and respond to situations affecting staff.
Good problem-solving skills, a strong sense of urgency, keen attention to detail, ability to work independently and be able to effectively manage multiple priorities in an environment under time and resource pressures.
Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
Successful record of creating and managing complex project plans, timelines, budgets, and critical paths.
Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
Ability to travel 10-20 % domestically and internationally.
Travere will require proof of vaccination status to perform onsite, face to face work or to become employed.
If working remotely, must be able to travel to the San Diego office at least once per month.
Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer