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Head of Quality

3 months ago

Remote, Oregon, United States Roivant Sciences Full time

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; 10 consecutive positive phase 3 trials; 6 FDA approvals; >10$B in global pharma partnerships and proceeds; expanding pipeline of assets across various modalities and therapeutic areas; successful commercial launch of 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.

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 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.

To learn more about our story and company culture, please visit us at

Position Summary:

Roivant is seeking a highly motivated Senior Director, Head of Quality, to develop and implement quality systems and oversee the function for the parent company and new co creation. S/He must work collaboratively across and between functions, geographies, and organizational levels to ensure Roivant is well positioned to anticipate and mitigate risks associated with clinical programs, product manufacture and regulations.

Key Responsibilities:

  • Responsible for the development, implementation, and strict adherence to a GxP quality program.
  • Develop phase appropriate processes and procedures for Roivant as well as select Vants, as needed.
  • Primary employee responsible for Quality decisions and execution on GMP, GCP, systems, qualification etc.
  • Oversee the drug substance, drug product, packaging/labeling/serialization, third-party logistics vendors for production activities of early and late-phase therapeutic areas.
  • Review and approve specifications affecting product quality and oversee the development of batch records, validation protocols.
  • Reviews and resolves quality issues with stakeholders and others including vendors, internal customers and production personnel.
  • Schedules and performs, as applicable, quality audits and reports findings to the company; ensures corrective action plans are developed there is a timely resolution of findings.
  • Prepares Quality Metrics for senior leadership supporting the quality function.
  • Ensure the appropriate Quality Management Systems in place to ensure GxP compliance.
  • Develop mutually agreeable Quality Agreements with Tier 1 vendors and vants. Support inspection readiness activities and associated Health Authority Inspections.
  • Develop/implement department specific standards and SOPs in support of the Quality System to satisfy best practices and regulatory requirements.
  • Work with management of GxP-regulated internal groups to identify process improvements for building compliance into the design and conduct of clinical activities.
  • Collaborate to ensure management of GxP regulated internal groups are actively engaged in improving compliance and addressing compliance risks.
  • Evaluate GxP compliance status in relationship to industry and Regulatory Agency expectations and assesses the effectiveness of corrective actions in response to internal and third-party audits.

Requirements:

  • Bachelor's Degree is required in Biological Science, Chemistry or related technical discipline.
  • 15+ years' experience in Biotech/Pharmaceutical industry, with ideally a minimum of 10 years in a supervisory capacity.
  • Expert working knowledge and interpretation of FDA/EU and ICH – GCP regulations and guidelines.
  • Broad and direct experience with regulatory authority inspections.
  • Strong experience working with outsourced support with track record of collaboratively engaging with external GxP 3rd parties to effectively execute Quality oversight.
  • Experienced in all phases of drug development is a plus.
  • Flexible in the face of shifting needs and/or priorities.
  • Able to interface well with all levels of personnel, including peers and other department heads such as: Clinical, Safety, Data Management, Biostatistics, Regulatory, CMC, and Project Management.
  • Experience with computerized systems and their associated compliance requirements.
  • Capacity to produce high quality results across multiple projects and demands, through effective prioritization, while working under short deadlines associated with a fast-paced dynamic scientific environment.
  • Excellent communications skills, both written and verbal.
  • Excellent teamwork, interpersonal skills and negotiation skills, both internally and externally.
  • Strategic thinker, open-minded and flexible to adopting new ideas.

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.

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