Associate Director/Director, Quality and GxP Compliance (Kinevant)

Kinevant Sciences, a wholly-owned subsidiary of Roivant, is focused on developing new therapies for rare auto-immune diseases, initially targeting sarcoidosis with an anti-GM-CSF monoclonal antibody (namilumab). The Company has recently initiated Ph 2 clinical trials in pulmonary sarcoidosis and cardiac sarcoidosis. Sarcoidosis is a multi-organ autoimmune disease with poor treatment options that affects up to 200,000 people in the U.S. The long-term vision for Kinevant is to successfully develop and commercialize namilumab for sarcoidosis and potentially other inflammatory orphan diseases, as well as in-license other promising drug candidates for orphan autoimmune and inflammatory diseases.

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: 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. Traditionally, Roivant provides all the capital required for Vant operations until the Vant becomes a public company. Roivant attracts, retains, and motivates entrepreneurial company builders that have deep domain expertise with competitive compensation and benefits, including stock option grants in the Vant.

Position Summary 

Kinevant is seeking a highly motivated AD/Director of Quality to develop and implement Kinevant’s Quality Systems, working closely alongside the SVP, Quality, Regulatory and Drug Safety. This is a unique role, broadly scoped role with an apprenticeship model which presents an accelerated growth opportunity with the possibility for development pathway into a Head of Quality role for the right candidate.  S/He must work collaboratively across and between functions, geographies, and organizational levels to ensure Kinevant Sciences speaks with one Quality voice externally, and that Kinevant is well positioned to anticipate and mitigate risks associated with clinical programs, product manufacture and regulations.

Responsibilities:

• Responsible for the development, implementation, and strict adherence to a GXP quality program.
• Develop and/or review standards, policies, and procedures for all functions and departments involved with or related to the production of all products.
• Collaborate with Roivant Quality to ensure compliance with their systems and that Kinevant specific procedures are operating cooperatively.
• Primary employee responsible for Quality decisions and execution.
• Enhance Quality culture across all Quality functions.
• Decision-making over the shipment of any product or products and accepts the responsibility for products following all regulatory and company standards.
• 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.
• Collaborates with Roivant to ensure adherence to mutually created Quality systems that ensure product quality during clinical trials and compliance with applicable GCP ICH guidelines and FDA/EMA/applicable global health authority requirements and expectations.
• Ensure the appropriate capabilities; procedures and mindset are in place to ensure GCP with a focus on data integrity / analysis and management.
• Utilize the Quality Management System and Health Authority requirements and expectations as the basis for building and executing the GCP management approach.
• Drive realization of one Quality Management System (QMS) throughout the company by supporting clinical trials establishing common Quality rules and oversight processes.
• Maintain Key Quality Performance Indicators for global clinical trials and design and implement remediation strategies for out of tolerance metrics.
• Support inspection readiness activities and associated Health Authority Inspections.
• Develop, maintain and implement internal and external processes to satisfy contractual and regulatory requirements.
• Develop/implement department specific standards and SOPS in support of the Quality System as needed.
• 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.
• Sign documents for activities as authorized and described by Kinevant policies, procedures and job descriptions.

Requirements: 

• Bachelor's Degree is required in Biological Science, Chemistry or related technical discipline.
• 10+ - 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 Contract clinical organizations is a plus. Capable of collaboratively engaging with external GXP 3rd parties to effectively execute Quality oversight.
• Strong experienced in all phases of biologic and small molecule 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.
• Motivated, committed and self-managed.
• Focused on practical, commonsense and sensible approaches to finding effective solutions with a focus on embedding strong quality and compliance behaviors.
• Willingness to work in a dynamic and changing corporate environment.
• Requires a flexible work schedule to accommodate program priorities.