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:
Nuvalent is searching for a dynamic Associate Director, GMP QA to join our growing Quality team. Reporting to the Director, Quality Assurance, the Associate Director, GMP QA will be responsible for supporting and maintaining high quality levels on Nuvalent drug substance, drug product, packaged drug products and finished goods by contract manufacturing organizations (CMOs). This Quality Assurance professional must possess strong leadership skills, and will assure the company, its affiliates and/or contractors associated with the manufacture, packaging, labeling, testing and distribution of products used for investigational clinical trials through commercial phases comply with cGMPs and standards as well as regulations of applicable authorities.
Responsibilities:
- Provide quality oversight and strategic guidance throughout the CMC lifecycle management of Nuvalent’s products
- Build out processes related to product launch and commercialization
- Lead Pre-Approval Inspection Readiness activities for CMOs
- Conduct product release activities for drug substances, intermediates, drug product and finished goods for all phases of development including review and approval of master batch records and executed batch records.
- Provide onsite oversight/monitoring of manufacturing campaigns as appropriate
- Coordinate QP release as appropriate
- Effectively interact with external contract manufacturers and testing laboratories as well as work as part of an internal multidisciplinary team to conduct, review and approve manufacturing, testing, and product complaint investigations
- Assist in preparing or reviewing CMC sections of regulatory submissions
- Manage and address associated Investigations, CAPAs, Change Controls, Material Review Boards, OOS, etc.
- Lead and actively participate in Continuous Improvement initiatives and projects, ensuring a focus on increasing both efficiency and quality output from all processes used by cross-functional partners
- Implement necessary Quality Agreements
- Represent the QA department on project teams
- Conduct audits of CMOs and Testing Laboratories
Competencies Include:
- 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
Qualifications:
- Bachelor’s degree in biology, chemistry, life sciences or a related field
- 10+ years’ experience of Quality Assurance experience in a cGMP manufacturing environment
- Strong knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical operations
- Experience in drug substance and drug product manufacturing is required
- Demonstrated application of the principles of cGMP and Quality Assurance. Direct experience with regulators (e.g., NDA, MAA submissions and/or inspections) required.
- Commercial labeling experience strongly preferred
- Small molecule experience required
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 “no-reply@greenhouse.io” 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.