Sr. Associate, FDA Process Improvement

GeneDx • Gaithersburg, MD

4d • Onsite

About The Position

The Process Improvement Senior Associate is responsible for providing technical, scientific, and/or clinical expertise in process improvement projects, focusing on optimizing workflows, ensuring quality compliance, and leading validation efforts in the molecular genetics lab. This role has a primary focus on supporting FDA and regulated lab development activities, while also contributing to broader process improvement initiatives as business needs evolve.

Requirements

• Bachelor’s degree in Molecular Biology, Genetics, Biotechnology, Genetic Counseling or a related field; PhD in Biology, Genetics or related field; MD or DO with experience in human genetics
• 4+ years of experience in a laboratory or process improvement setting
• Experience working in an FDA-regulated laboratory environment, including familiarity with GxP principles (GMP, GLP, or GCP as applicable) and IVD development workflows; CLIA/CAP/NYS laboratory standards and LDT experience preferred
• Familiarity with relevant FDA regulatory frameworks, including 21 CFR Parts 820/QMSR, 21 CFR Part 11, ISO 13485, and/or ISO 14971, is preferred
• Strong data analysis, problem-solving, and project management skills
• Experience with regulatory compliance, documentation, and validation principles
• Experience with CAPA systems, deviation management, and quality event documentation

Nice To Haves

• Familiarity with Lean Six Sigma or similar methodologies is preferred
• Either ABMGG Diplomate or equivalent, certified in at least one specialty, or Certification by the American Board of Genetic Counseling (ABGC) or equivalent is required for relevant positions.
• For Genetic Counselors: Licensure is required in the state where the employee works, if applicable. Genetic counseling licenses for additional states may be required at the discretion of GeneDx.

Responsibilities

• Support validation efforts for new and improved production processes, including analytical validation, verification, and FDA submission-related activities (e.g., Pre-Submission meetings, IVD development), as well as protocol development, data collection, and documentation.
• Support design control activities and maintain associated documentation (DHFs, technical files) in accordance with applicable FDA regulatory requirements.
• Support investigations, root-cause analyses, CAPAs, and quality event documentation in partnership with Quality and Regulatory Affairs.
• Analyze laboratory and production workflows to identify process inefficiencies and opportunities for improvement.
• Develop and implement workflow optimizations and maintain process documentation.
• Develop and refine SOPs and training materials for process improvements.
• Provide troubleshooting support for complex process inefficiencies.
• Mentor junior associates on process improvement methodologies and best practices.
• Ensure all process changes meet regulatory requirements and quality standards.
• Work with cross-functional teams to communicate and implement findings.
• Support and train production personnel in process improvement and/or new process workflows.
• Performs other duties assigned in support of the team or department.

Benefits

• Competitive compensation and benefits that reflect local market practices and legal requirements in each country where we operate, helping employees thrive both professionally and personally.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior