Quality Systems Specialist

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:

Reporting to the Associate Director, Quality Systems, the Quality Systems Associate will be responsible for assistance with the daily administration of the quality management system document/records management. This person will assist with providing technical and compliance support that will influence, educate, and positively impact Nuvalent data integrity and support Nuvalent’s quality culture.

Responsibilities:

• Assist with review of documents under revision, issuance of records, tracking of controlled documents, and management of the Quality Files.

• Provide assistance to users on the process of writing SOP’s and other documents.

• Assist with administering GxP implemented quality management systems, assign and track training.

• Track procedural document record archives for all GxP functions.

• Track and trend deviations, change controls, CAPA and product complaints to closure.

• Responsible for delivery of training programs, as well as, prepare and provide training reports.

• Provide training follow-up reminders and status updates for assigned training.

• Assist with providing system admin technical support for GxP implemented electronic systems.

• Assist with the management of Audit Program activities including document management, tracking, notifications, metrics, and reporting.

• Supports all training activities within the Quality team for the entire company.

Competencies:

• Cross-functional collaboration, excellent communication skills, flexibility with changing priorities, strong attention to detail, and the ability to work well under pressure and take on unfamiliar tasks.

• Ability to work productively primarily from home in a fast-paced, results-driven, highly accountable environment where you can demonstrate initiative and make a clear impact.

• Ability to think critically with strong attention to detail.

• Excellent organization and multi-tasking skills and ability to drive and deliver multiple projects within project scope and timelines.

Qualifications:

• Bachelor’s degree in biology, chemistry, or a life sciences field is preferred or related experience.

• 3+ years of experience in the pharmaceutical industry.

• Experience in Document Control and Quality Events monitoring.

• Experience with Electronic Quality Systems.

• Experience with ELMS and Electronic Training Systems.

Annual Salary Range
$73,000—$90,000 USD

Nuvalent provides 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 third-party 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 "@nuvalent.com" email accounts. Automated system response emails from our Greenhouse applicant tracking system come from a “[email protected]” 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 in-person.

If you believe you have been contacted by anyone misrepresenting themselves as an employee of Nuvalent, please contact Nuvalent at 857-357-7000. Thank you.