Senior Director, GCP, GLP & GVP Quality Assurance

Location: Roivant Sciences, Inc., 151 West 42nd Street, 15th Floor, New York, NY 10036

At Roivant, we are passionate about discovering and developing new drugs to impact patients’ lives. Since its inception in 2014, Roivant has launched over 20 portfolio companies (Vants), overseen 5 successful IPOs, established a $3B partnership with a global pharma, built a pipeline of over 40 assets across various modalities and therapeutic areas, and delivered 8 successful phase 3 readouts. Roivant is currently building new capabilities in drug discovery and expanding its existing development engine to become the world’s leading tech-enabled pharmaceutical company.

Our goal is to improve human health by rapidly discovering, developing, and delivering innovative medicines and technologies to all patients. Our success is predicated on attracting and retaining top talent, generating new ideas and promoting an open and collaborative culture.

We embrace diversity across all dimensions and levels of the organization, and we strive to ensure every employee is supported in reaching their full potential. We hire motivated people with diverse backgrounds, identities, experiences, and skillsets. We are committed to fostering an inclusive culture where all employees feel valued, respected, and empowered to create value for patients.

Position Summary:

Roivant’s Quality Team is seeking an energetic, customer-oriented, and prospective-thinking Clinical QA Leader with experience covering GLP, GCLP and GVP/Safety activities within an R&D unit.  Quality is building a leadership team to serve Roivant beginning in later stages of due diligence and extending into early clinical phases of development with trials conducted across major world markets.  The Clinical QA leader will partner with the Clinical Development and Clinical Operations team to ensure compliant approaches to the setup, initiation, and conduct of clinical trials are implemented.  This leader will also manage a small team to perform the clinical site QA audits as well as auditing of the TMF, CSRs, TLFs, and other clinical trial documentation.  This role will interface with the Regulatory Affairs team when dossier review is performed prior to submission.  This position is a remote opportunity and will report to the Vice President of Quality.

Key Responsibilities:

  • Lead Roivant’s Clinical QA function while promoting a culture of quality by collaborating across all Vant Business Units, departments, and levels of management to accomplish company objectives and represent Clinical Quality.
  • Develop, implement, and maintain GCP/GLP/GPVP quality oversight systems through development of procedures that follow 21 CFR Part 50, 56, 58 and 312 along with ICH and other relevant guidance documents as well as emerging regulations in a fit-for-purpose manner for Roivant’s Quality Management System
  • Drive and support CQA compliance for ongoing and planned clinical trials.
  • Support and drive a robust risk-based vendor management program.
  • Partner externally to perform effective audits of vendors (CROs), investigator/clinical sites, and ensure documents are tracked and maintained within standards (e.g. Trial Master Files, Clinical Study Reports, Protocols, etc.).
  • Oversee audit plans and activities, actively leverage audit outcomes/trends to achieve sustained improvement in clinical trial conduct and reporting while championing the highest standards of compliance.
  • Lead the GCP, GLP, and GPVP inspection management program, including inspection readiness activities, inspection conduct, and preparation of responses to health authorities.
  • Directly interface with Clinical Development and Clinical Operations for GCP audits of internal processes. Promote collaboration to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines.
  • Collaborate and work closely with the Roivant R&D team, study directors and animal sites to effectively and efficiently set up the overall GLP oversight programs to ensure compliance with US, UK, EU and other regulatory jurisdiction requirements.
  • Work with Clinical Operations and Regulatory Affairs to review IND and NDA submissions to ensure data and documents meet GCP guidelines. Perform QC checks of relevant clinical documents and regulatory dossiers, e.g., Investigator's Brochure, CRF, Clinical Study Reports and non-clinical/clinical sections in the IND/NDA/BLA/MAA submission to ensure data integrity and accuracy
  • Work with Clinical Operations and Pharmacovigilance to develop a robust and integrated risk management program in accordance with ICH E6 (R2), including systems and processes associated with product complaints.
  • Work collaboratively with GMP QA Operations teams. Ensure manufacturing and packaging of clinical materials meet study and trial requirements, and with GMP QA to ensure testing and stability is initiated compliantly and tested on time.
  • Evaluate quality events, incidents, queries, and complaints and perform risk analysis on any GCP violation reported from the clinical site or CROs (including CTM service provider), take actions to remediate, and communicate to senior management on the overall compliance status.
  • Support the development and delivery of GCP, GLP and GPV training of internal company employees.
  • Planning, coordination, control, and continuous improvement of processes and systems to assure the quality & compliance of clinical studies. Provide input and change management for quality improvements affecting CQA processes.
  • Provide leadership and strategy in spear heading Quality initiatives in line with company objectives.
  • This role may also have a SPoC Quality Lead responsibility to manage new Vants, performing effectively as the Vant Head of Quality
  • May participate in due diligence activities toward licensing/acquisition as well as the knowledge transfer process
  • Other CQA related duties, as assigned.

Qualifications and Skills

The ideal candidate for this position will have demonstrated in-depth experience of establishing and managing CQA functions in compliance with GCP, GLP and GPVP applicable regulations.

  • Master's degree or equivalent in a science, health care or other related field and significant experience in an FDA-regulated environment. Minimum of 15 years of experience in the pharmaceutical industry with a GCP, GLP and/or GPV focus, ideally covering all clinical phases through commercial drug product, with at least 5 years in a GCP quality/compliance role.
  • Broad knowledge of clinical processes and procedures, electronic documentation systems, and GCP, GLP and GPVP regulations and guidance with demonstrated effectiveness in maintaining CQA control processes for compliance with regulations.
  • Experience conducting quality audits of CROs and Investigational sites.
  • Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
  • In-depth knowledge of FDA and ICH regulatory requirements. Experience with EMA, MHRA and WHO regulations a plus.
  • Demonstrates initiative and proactively provides collaborative support to the clinical team as a credible communicator. Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction to follow through with specific tasks.
  • Continuously demonstrates a positive, 'can do' and service-oriented attitude.
  • Excellent interpersonal, verbal, and written communication skills with commitment to accuracy. Ability to communicate and work independently with scientific/technical personnel.
  • Direct report management experience
  • Skilled in developing collaborative internal and external relationships with experience in building teams, through coaching and development.
  • Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
  • Ability to think critically and demonstrate troubleshooting and problem-solving skills.
  • Self-motivated, detail-oriented, and comfortable in a fast-paced, rapidly evolving, highly unique company environment with minimal direction and able to adjust workload based upon changing priorities.
  • Must be competent in, and comfortable with, managing through influence and developing champions to advance the Roivant QA agenda and objectives.

Roivant Sciences 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.

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