Senior Manager GCP Pharmacovigilance PV QA
Senior Manager GCP Pharmacovigilance PV QA
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Job Description
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 earlystage company bringing together experienced scientists and industry veterans with a proven track record in drug discovery oncology drug development and company building.
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 handson with internal and external partners and will develop and lead riskbased quality assurance activities to support Nuvalents 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 riskbased 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 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 riskbased clinical Quality Assurance management system
Identify QA and compliance related issues and implement solutions to ensure timelines are maintained
Manage development of riskbased 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/PVrelated 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 crossfunctional team meetings
Ability to work independently manage multiple priorities and execute on goals. Proven ability to work in a fastpaced environment handling multiple demands and shifting priorities with flexibility and willingness to adapt
Must be willing to travel domestically and internationally an average of 1015
Nuvalentprovides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion race creed color sex sexual orientation alienage or citizenship status national origin age marital status pregnancy disability veteran or military status predisposing genetic characteristics or any other characteristic protected by applicable federal state or local law.
Nuvalent is aware that many companies are dealing with fraudulent job postings on thirdparty employment search sites and/or individual(s) or entities claiming to be employees of such companies. Those involved are offering fraudulent employment opportunities to applicants often asking for sensitive personal and financial information and using such information for criminal activities.
Please be advised that all legitimate correspondence from a Nuvalent employee will come from @ email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a email address. There are no variations of these email addresses and Nuvalent would not request personal and/or financial information via email. Job opportunities would only be extended after a completed job application is submitted by a candidate and a thorough interview process including 1:1 and/or group interviews via phone video conferencing and/or inperson.
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Required Experience:
Senior Manager
Employment Type
Full Time
