Director/Senior Director, Product Quality Operations, Telavant (Remote)

Telavant, a Roivant company, is a clinical-stage biotechnology company developing innovative therapies to treat inflammatory and fibrotic diseases.  Telavant’s first investigational product, RVT-3101, is a fully human monoclonal antibody targeting TL1A. We are developing RVT-3101 as a potential best-in-class and first-in-class subcutaneous therapy in ulcerative colitis and Crohn’s disease, including for patients with a prospectively defined biomarker who may benefit from a precision approach.

To learn more about our company and pipeline, visit us at https://www.telavanttx.com/.

About Roivant

Roivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients and their families. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 9 successful phase 3 readouts since 2019; launched VTAMA®, (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults.  Building upon this track record of establishing a robust pipeline through in-licensing and acquisition of novel assets and technology platforms, Roivant is currently building new capabilities in drug discovery and expanding upon existing development disciplines to become the leading tech-enabled pharmaceutical company.

Position Summary

The Product Quality Operations role will be the primary Quality Leader for the Chemistry, Manufacturing, and Controls (CMC) unit at Telavant, Inc.  The successful candidate will ensure that the technical CMC strategy and operations for RVT-3101 meets Telavant Standards for GMP compliance through an active partnership with the CMC teams.  The successful candidate must have a deep scientific background with Quality experience and has led projects across multiple CMC areas for both biologics and pharmaceuticals.   They will be expected to operate simultaneously at a strategic and tactical level.  Additionally, this leader will assist with Supplier Quality Management and other QA Operations, including GLP and related laboratory functions.  This position reports to the Chief Medical Officer.  This position is a remote, work from home opportunity. 

Responsibilities

• Attend all CMC product teams’ meetings providing timely quality strategies and tactics to the project team enabling rapid program progression to phase-appropriate compliance expectations
• QA review/approval of GMP records and documentation, including although not limited to, batch records, test method validations, specifications, deviations/investigations, CAPAs
• Assist in the creation, development, and implementation of procedures for CMC and GLP operations or other laboratory functions
• Assist with the Supplier Quality Management program for all GXP areas
• Ensure that CMC has the best Quality guidance possible to simultaneously optimize the triple constraint within the framework of compliance
• Maintain a continuous improvement focus facilitating the growth of the quality mindset in Telavant
• Participate in other assignments, as needed.

Skills, Qualifications, and Requirements

• BA/BS degree with 15+ years of experience in the pharmaceutical industry (MS +10; PhD + 8) with a scientific or engineering degree
• Deep knowledge of the product development lifecycle (Phase 1 through commercial) and application of phase-appropriate quality for manufacturing, analytics, and formulation/stability for both biological and pharmaceutical assets; GMP experience is required.
• Practicing knowledge of compendial affairs topics related to analytics, primary containers and raw materials at a minimum.
• Development and/or critical evaluation for Justification of Specifications for biologics and pharmaceutical assets.
• Experience in quality assurance as related to program development for CMC Teams and the relevant regulations across major markets.
• A strategic thinker who can work seamlessly with other team members and brings solid technical capabilities to effectively merge science and quality meeting program timelines.
• Experience with Supplier Quality Management programs; auditing experience a plus.
• GLP experience, including bioanalytical assays, is highly desired.
• Experience with managing either direct reports and/or consultants.
• Proficient in quality management platforms and tools, specifically Veeva.
• Resourceful and relentless: independently capable of seeking information, solving conceptual problems, corralling resources, and delivering results in challenging situations.
• Excellent verbal and written communication skills; ability to deal with complex problems, determine and evaluate risk, and present recommendations and findings in a clear, concise format.
• Experience in fast paced, start-up environments is preferred - able to work comfortably under pressure, frequently changing landscape and tight deadlines.

Telavant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. 

We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!