Roivants mission is to systematically reduce the time, cost, & risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients & their families.
The Roivant R&D team is responsible for: 1) working hand in hand with Investments & Business Development to establish the scientific rationale & initial development strategy for in-licensing opportunities; 2) discovery efforts focused on integrating computational & medicinal chemistry methods in order to establish R&D leadership positions in oncology, immunology & rare diseases; 3) providing tactical & strategic R&D support to stand up new portfolio companies (Vants) & advance development efforts across the portfolio.
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 & therapeutic areas; 8 successful phase 3 readouts since 2019. Building upon this track record of establishing a robust pipeline through in-licensing & acquisition of novel assets & technology platforms, Roivant is currently building new capabilities in drug discovery & expanding upon existing development disciplines to become the first large tech-enabled pharmaceutical company.
Position Title: Head of Quality
Position Location: New York, New York (location arrangements are flexible, however)
Manager Title: Head of Quality
The Head of Quality is responsible for the strengthening & building upon existing capabilities in Roivants quality assurance program & systems. This person will oversee all aspects of quality assurance in all therapeutic development & manufacturing activities, directing cGxP quality related activities across the organization to support global regulatory submissions (NDA/MAA, etc). This person will ensure that good practice regulations (GxP) have been met throughout the development cycle of all products in the portfolio. The role will define & drive the GxP Quality vision & mindset of the entire company, build internal & external relationships as necessary to support QA activities & responsibilities, & provide leadership & guidance to the organization on quality matters. The successful candidate will drive, promote & embed a culture of ethics, integrity & continuous improvement to ensure compliance & excellence in quality.
- Oversee the Roivant quality system, & associated quality activities (e.g. document management, vendor management, CAPAs, internal audits, etc.) to ensure it continuously meets regulatory & business requirements & expectations throughout the drug development lifecycle
- Monitor key quality system metrics, process indicators, & overall health of the Quality Management System (QMS) to proactively identify & address issues, & ensure its continuous improvement
- Oversee the training of appropriate regulatory & quality requirements & expectations to ensure internal & external stakeholders achieve quality objectives & maintain a state of control
- Oversee the escalation, management, & timely resolution of critical quality issues that may impact the business
- Serve as primary quality representative during inspections by a regulatory authority & direct the resolution & response to the authorities.
- Collaborate with clinical team functional areas (Clinical Operations, CMC, etc.) to present & maintain quality system expectations & assess quality risks
- Perform detailed review of policies, procedures, work instructions, clinical trial protocols, regulatory submissions, internal deviations, CAPAs & other essential documents prior to their Quality Assurance acceptance or approval.
- Maintain knowledge of, & advise on, industry trends & standards, & regulatory requirements & expectations as they relate to quality & compliance
- Conduct all duties in compliance with country specific regulations, applicable SOPs, & other applicable guidelines
Skills, Qualifications, & Requirements:
- Bachelor's degree or Master's degree in related Life Sciences discipline
- 15+ years of relevant experience in GxP, QA management or QA leadership positions in a Biotech or Pharmaceutical industry
- Thorough knowledge of global GCP & GMP requirements for all phases of development to commercial
- Strong understanding of US FDA & EU EMA regulations & ICH guidelines for development & manufacture of small molecule & biologics
- Familiar with ICHQ9 principles & has demonstrated the ability to utilize Quality Risk Management principles in everyday practice
- Strong understanding of risk assessment & risk management fundamentals/tools.
- Excellent communication, negotiation, & presentation skills; maintains high ethical standards, & enjoys working with people & information, making decisions, problem solving, making a difference & working in a leadership role
- Strong attention to detail & respect for the need of accuracy of information
- A hands-on leader with previous managerial experience who leads by example, inspires, & empowers team members
- Demonstrated ability to work effectively in a cross functional team environment & independently in a remote work setting, as necessary
- Excellent problem-solving & decision-making skills