Manager, GCP Quality Assurance

The Company:
With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer.  Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. 

The Role:

In this newly created role, the Manager, GCP QA will be responsible for conducting GCP QA activities.  Reporting to the Associate Director of GCP QA, this individual will have responsibility for QA oversight of GCP activities at Nuvalent, its  contract research organizations (CROs) and Investigator Sites to ensure that outsourced third parties (CROs and other GCP service providers) are compliant and prepared for potential Sponsor and Regulatory Inspections and to ensure that the appropriate processes, systems and activities are in place and performed to protect the rights, safety and welfare of our clinical patients. This individual will also oversee, assess, and directly work to continuously improve GCP quality processes and to support the state of GCP compliance at Nuvalent.  This is an opportunity to help grow the GCP QA function and ensure high quality execution of clinical trials from first in human through commercial marketing authorization.  This individual will be hands-on with internal and external partners.

Responsibilities:

• Contribute to the development, implementation, and maintenance of GCP Quality Systems and SOPs
• Provide consultation in interpretation of regulations/guidelines, as they apply to GCP practice, awareness of regional regulatory requirement, and phase of study.
• In partnership with the Clinical Operations, Pharmacovigilance, and Regulatory teams, contribute to the design and implementation of a risk-based clinical Quality Assurance management system.
• Identify QA and compliance related issues and implement solutions to ensure timelines are maintained.
• Assist with establishing metrics and reporting the state of GCP Quality and compliance of clinical trials to senior management.
• Support clinical quality oversight activities for multiple programs within Clinical Development
• Assist with preparations for GCP inspection-readiness for Nuvalent as well as CROs and investigator sites.
• Assist with managing GCP Inspections of Nuvalent.
• Continue to develop as an SME for areas of responsibility during regulatory inspections and assist in managing inspection activities.
• Ensure Clinical Development activities are compliant with cGCP, cGLP, FDA, ICH, EMA regulations and guidelines and industry standards.
• Review key safety, clinical and regulatory documents, such as DSUR, IB, IND and NDA
• Provide QA oversight and auditing of TMFs.
• Assist and/or oversee consultant mediated audits; develop, recommend, and follow up on corrective actions.
• Support the planning and conduct of complex audits / mock inspections in agreement with QA management.
• Assure through audits that non-clinical CROs, clinical CROs, clinical sites and supporting services are operating in compliance with the Company’s quality program, regulations/guidelines and SOPs and are acceptable for performing clinical studies and related services.
• Manage development of risk-based auditing schedules
• Oversee the conduct of the GCP vendor procedures.
• Keep abreast of industry developments – forthcoming regulations, guidance, best practices, etc.

 

Competencies Include:

• Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.
• Communication and Teamwork – Ability to effectively express ideas in written and oral context; to work co-operatively with others; genuine desire to be a part of a team and contribute to organizational and team goals.
• Effective Planning – Embed discipline and thoroughness in our approaches.
• Perseverance – Pursues tasks with energy, drive, and initiative, even in the face of adversity; comfortable in a results-driven, highly accountable environment where you can make an impact.
• Problem Solving – Ability to understand a situation or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
• Relationship Building – Builds productive working relationships across a diverse spectrum of people.
• Organizational Skills – Ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure

 Qualifica