Director/Senior Director, Product Quality Operations

Job Details

Location:
New York, NY
Department:
Research & Development
Posted Date:
July 1, 2021

Job Summary

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:  launched over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 8 successful phase 3 readouts since 2019.  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 first large tech-enabled pharmaceutical company.

As the centralized engine for innovation and development the Roivant R&D team is responsible for: 1) discovery efforts focused on integrating computational and medicinal chemistry methods in order to establish R&D leadership positions in oncology, immunology and rare diseases; 2) working hand in hand with Business Development to establish the scientific rationale and initial development strategy for in-licensing opportunities; 3) providing tactical and strategic R&D support to stand up new portfolio companies (Vants) and advance development efforts across the portfolio. 

Position Summary: 

The Product Quality Operations role will be the primary Quality Leader for the Chemistry, Manufacturing, and Controls (CMC) unit at Roivant Sciences.  The successful candidate will ensure that the technical CMC strategy and operations for each asset meets the Roivant 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 as well as 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 oversee Supplier Quality Management and other QA Operations, including GLP and related laboratory functions.  This position reports to the VP, Head of Quality, Roivant R&D.  This position is a remote, work from home opportunity. 

Responsibilities:

  • Attend all CMC product teams' meetings providing timely quality strategies and tactics to Vants 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
  • Oversee 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 Roivant R&D and Vants
  • Participate on due diligence activities, as needed

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
  • 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 direct reports and 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