Roivant Sciences is hiring a
Head of Quality

Summary

Roivant Sciences is seeking a Senior Director, Head of Quality to develop and implement quality systems and oversee the function for the parent company and new co-creations. The role requires expertise in GxP regulations, experience in all phases of drug development, and strong interpersonal skills.

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
• 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

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

Preferred Qualifications

Experienced in all phases of drug development is a plus