Senior Manager, GCP, Quality Assurance

The Role:

Reporting to the Director, GCP Quality Assurance, the Senior Manager, GCP/PV QA will have responsibility for QA oversight of GCP/PV activities at Nuvalent, its contract research organizations (CROs) and Investigator Sites to ensure that outsourced third parties (CROs and other GCP & PV service providers) are compliant and prepared for potential Sponsor and Regulatory Inspections. This individual will also oversee, assess, and directly work to continuously improve GCP/PV quality processes and to support the state of GCP/PV compliance at Nuvalent.  

This individual will be hands-on with internal and external partners and will develop and lead risk-based quality assurance activities to support Nuvalent’s GCP and PV Organization.  The Senior Manager, GCP/PV QA will interface with the Nuvalent Clinical Study Team Members and the PV department, as needed, to provide GCP/PV compliance guidance.  In this role, you will establish and maintain a risk-based audit program to ensure effective audits of Nuvalent GCP/PV vendors, systems/processes, clinical trial sites, and contract service providers are conducted.  Other activities include identifying, verifying and tracking Quality Events (e.g., Deviations and CAPAs) to completion, informing management of Quality Event metrics with recommendations for resolution/corrective actions, leading or helping prepare for GCP/GVP health authority inspections, provision of regulatory compliance and QA guidance to the Clinical Development and PV teams, and providing QA input into GCP/PV related policies/procedures.

This individual is responsible for ensuring that the appropriate quality processes and systems are in place and performed to protect the rights, safety, and welfare of our clinical patients. This individual oversees, assesses, and directly works to continuously improve GCP/PV quality processes and to support GCP/PV compliance at Nuvalent, ensuring high quality execution of clinical trials from first in human through commercial marketing authorization. 

Responsibilities:
•    Contribute to the development, implementation, and maintenance of GCP/PV Quality Systems and SOPs
•    Provide consultation in interpretation of regulations/guidelines, as they apply to GCP/PV practice, awareness of regional regulatory requirements, 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
•    Manage development of risk-based auditing schedules
•    Assist and/or oversee consultant mediated audits; develop, recommend, and follow up on corrective actions by reviewing audit reports, evaluating the impact of audit findings and tracking audit actions to closure
•    Evaluate the adequacy and completeness of Quality Events (e.g. Deviations and CAPAs) and effectiveness checks (ECs) originated from audits, inspections and/or deviations
•    Maintain quality agreements, quality management plans, or similar with GCP/PV service providers
•    Assist in the review and provide input into the quality sections of the PSMF
•    Ensure that all GCP/PV-related training is implemented in a timely and effective manner both at Nuvalent and within external/contracted PV service providers 
•    Assist with establishing metrics and reporting the state of GCP/PV Quality and compliance of clinical trials to senior management
•    Support clinical/PV quality oversight activities for multiple programs within Clinical Development
•    Assist with preparations for GCP/PV Regulatory Inspections of Nuvalent as well as CROs and investigator sites; act as an SME for areas of responsibility during inspections and assist in managing inspection activities
•    Review key clinical, safety and regulatory documents, such as DSUR, IB, IND and NDA
•    Provide QA oversight and auditing of study TMFs
•    Keep abreast of industry developments – forthcoming regulations, guidance, best practices, etc.

 
Competencies Include:

•    Excellent problem solving, communication and organization skills
•    Flexibility with ambiguity, changing priorities, strong attention to detail, ability to work well under pressure and take on unfamiliar tasks
•    Ability to work in a collaborative environment, drive to learn and improve skills 
•    Ability to strategically plan, organize and manage multiple projects simultaneously 
•    Ability to prioritize tasks/issues and identify risks in the future, raising awareness of potential issues in a proactive manner
•    Strong work ethic, ability to meet deadlines and recognizes when the need to flex work responsibilities and deliver outside core hours helps us to deliver on our value of patient impact

Qualifications:

•    BA/BS (or MS) or equivalent experience in a scientific discipline with 8+ years’ work experience (or an equivalent combination of education and work experience) in PV QA
•    Expertise in and ability to interpret and apply GCP/PV EU, FDA, and ICH regulations and guidelines
•    Critical thinking skills to analyze and communicate compliance related information and understand and communicate the associated risk
•    Experience auditing GCP/PV service providers, and supporting internal systems audits
•    Regulatory inspection and inspection readiness experience
•    Experience leading document review (source data verification) initiatives for example: DSUR, IB, NDA, CSR, etc., deploying both internal and external resources, in a compressed timeline to meet corporate objectives
•    Proficiency in study monitoring activities
•    Excellent communication, writing and presentation skills for effectively interfacing internal and external organizations and collaborators
•    Ability to lead and organize cross-functional team meetings
•    Ability to work independently, manage multiple priorities, and execute on goals. Proven ability to work in a fast-paced environment, handling multiple demands and shifting priorities with flexibility and willingness to adapt
•    Must be willing to travel domestically and internationally, an average of 10-15%