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Associate Director, Quality Assurance

NextCure, Inc.
Beltsville, MD
Start date
Mar 10, 2023

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Quality, Quality Assurance, Quality Control
Required Education
Masters Degree/MBA
Position Type
Full time

Job Details

NextCure is a growing clinical-stage biopharmaceutical company located in Beltsville focused on discovering and developing first-in-class immunomedicines for the treatment of cancer and other diseases. NextCure is committed to professional development in the context of learning, managing, and developing its employees. We create a unique environment for our employees, providing exposure to various facets of our operations cultivating career growth and development. We are excited about the ongoing work at NextCure and invite you to come join us in the culture and build your career in an environment that nurtures professional growth and development.

NextCure is seeking a highly motivated Associate Director of Quality Assurance to oversee our Quality Assurance (QA), Quality Control (QC), Quality Systems groups. As an Associate Director of Quality Assurance, you will develop and oversee robust and sustainable quality systems that ensure that manufacturing and quality control activities are conducted in compliance with current good manufacturing practices (cGMP), GCP, GLP, GxP, FDA requirements, EU Annex 1 and 11 preferable, and various pharmacopeia and internal institutional requirements. The candidate must thrive and adapt to a fast-paced, innovative, and changing environment.


  • Continue advancement of Quality Systems and perform executive QSMR quarterly review.
  • Fully support a pipeline development, and clinical manufacturing.
  • Implementing and supporting new cutting-edge technologies including automation systems.
  • Provide leadership, coaching, and mentorship of the Quality Assurance group.
  • Lead the Quality department in all GxP functional areas (GMP, GLP, GCP, GxP document control, GxP training) as we are transitioning from discovery through product development.
  • Manage the vendor qualification and requalification program, including vendor audits, quality and technical agreement.
  • Oversee the document control, change control, and enforce compliance of all the company’s SOPs, GMP and FDA guidelines and applicable regulations.
  • Oversee root cause analysis (RCA) of non-conformance events and deviations and assist team on identifying the correct and applicable CAPA and follow up on CAPA effectiveness check.
  • Maintain an efficient workflow to facilitate the operational excellence.
  • Establish and maintain an efficient and complaint validation program including process validation, cleaning validation, computer software validation, and instrument qualification.
  • Keep current on changes in industry and regulatory standards for GXP requirements and advise on business impact.
  • Partner with manufacturing, Quality Control, materials management, and facility for compliance alignment.
  • Ensuring employees and consultants are appropriately qualified and trained.
  • Provide compliance guidance to Product Development and Operations teams.
  • Ensure manufacturing and testing, clinical studies, and clinical trials are compliant with applicable.
  • Support site inspection, onboarding training, and yearly required compliance training.

Required education and experience

  • M.S. degree in Chemical Engineering, Biochemistry, Chemistry, Cell Biology, or a related field with relevant thesis work and or appropriate experience required
  • PhD in biochemistry, chemistry, bioassays, molecular biology, or microbiology preferred
  • At least fifteen (15) years of experience in the biotech/pharmaceutical industry, with at least five (5) of those years being experience in Quality and five (5) in a supervisory role
  • Knowledge and experience in principles and practice of current Good Manufacturing Practices (cGMPs), CMC, Clinical Operations, and Pharmacology/Toxicology is beneficial
  • Knowledge in Good Laboratory Practices (GLPs) for FDA expectations preferred
  • Solid knowledge in FDA regulations, especially the GMP
  • Experience with writing and reviewing regulatory submissions (IND, IMPD) and inspections


  • Proven experience in developing, qualifying, and validating analytical methods to support product development and regulatory filings.
  • Sound understanding of regulatory and compendial requirements for early stage through commercialization of products.
  • Good understanding of requirements outlined in ICH Guidelines and FDA guidance documents.
  • Substantial experience in a regulated biotech/pharmaceutical industry including manufacturing, quality assurance, quality control, R&D, and drug regulatory affairs.
  • Experience of sterile manufacturing (cleanroom).
  • Collaborative and superior influential and negotiation skills.
  • Details-oriented, strong analytical and problem-solving skills.
  • Ability to rapidly learn new skills and accept new ideas.
  • Flexible and able to adapt to changing circumstances while maintaining a focus on quality.
  • Passionate about scientific innovation, self-starter, goal-driven, and strive to continuously build knowledge and skills for personal, professional, and organizational growth.

NextCure is an Equal Opportunity Employer and offers a competitive salary and benefits package in a scientifically engaged team work environment.


NextCure is a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases by restoring normal immune function. We view the immune system holistically and, rather than target one specific immune cell type, we focus on understanding biological pathways, the interactions of cells and the role each interaction plays in an immune response. Through our proprietary Functional, Integrated, NextCure Discovery in Immuno-Oncology, or FIND-IO, platform, we study various immune cells to discover and understand targets and structural components of immune cells and their functional impact in order to develop immunomedicines. We are focused on patients who do not respond to current therapies, patients whose cancer progresses despite treatment and patients with cancer types not adequately addressed by available therapies.

Cancer is a complex disease where cells in the tumor microenvironment promote tumor progression, immune evasion and suppression of anti-tumor immune responses. While therapies targeting inhibitory or immune checkpoint molecules have shown important success in many cancers, not all patients benefit from these therapies (non-responders), and many develop resistance after initial treatment. NextCure is identifying novel tumor-specific interactions and mechanisms of immune regulation to generate a sustainable product pipeline to address these patients in need.

NextCure brings significant experience and innovation in cancer immunology. The company’s FIND-IOTM technology provides a large repertoire of function-based screens and imparts a unique understanding of cell surface molecular interactions between immune and diseased cells. We are using this important knowledge to rapidly develop and advance novel biologics that impact suppressive myeloid cell populations, T cell subsets, and other cell populations within the tumor microenvironment to restore anti-tumor activity and improve clinical response rates and outcomes for patients.

Stock Symbol: NXTC

Find Us
9000 Virginia Manor Rd. Suite 200

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