Quality Assurance Manager

New York, New York
Theery

Job Description

We are seeking a highly motivated individual to join our team of talented scientists and engineers in a highly collaborative startup environment at the intersection of Immunology, AI, and new genomic technologies. This position offers an opportunity to work with state-of-the-art genomic technologies on a diverse set of projects related to human cancer immunology and autoimmunity. The successful candidate will design, implement and maintain a robust QA program, collaborating closely with our scientific, operations, and computational teams. The successful candidate will be responsible for ensuring compliance with relevant regulatory programs and lead both the strategy and tactics of a QA program that supports our business goals.

Key Responsibilities

• Implement a program that promotes quality across the enterprise and following work portfolios;
• Next-Generation Sequencing
• Genomic Assays
• Accessioning processes
• Sample Management
• Incoming inspections
• CLIA

• Lead Quality Management System development and implementation
• Lead ongoing development and execution of their QMS including strategy and policy
• Establish ongoing training for colleagues on their QMS and Document Control System
• Lead activities to maintain compliance with contractual and legal obligations
• Manage the preparation for external inspections by accreditation and certification agencies
• Review, approve and manage compliant standard operating procedures (SOPs)
• Perform and manage audits of internal processes and systems
• Ensure that quality activities and records are in compliance with SOPs and regulatory requirements; ensure proper documentation of quality activities
• Report on quality metrics, corrective and preventive action status, internal/external audit results
• Responsible for assuring that corrective actions and preventive actions are established, tracked trended, and proved effective
• Work with their IT team in the development and implementation of compliant biorepository data collection and specimen management systems
• Responsible for company compliance with regulations regarding equipment, instrumentation, safety, security, and monitoring systems
• Perform as an internal and external liaison communicating Quality Control (QC) strategies, tactics, and requirements
• Provide guidance and interpretation of quality standard requirements for functional areas
• In association with regulatory affairs, ensure policies and procedures are compliant with ethical standards for human tissue use as defined by regulatory agencies
• Stay abreast of changes in quality standards, regulations, quality metrics, and audit techniques

Requirements

• BS degree in a Life Sciences or related field required
• 3-5 years experience in Life Science Quality Assurance Management. Experience in Six Sigma or LEAN preferred
• Experience in QMS design, implementation, and maintenance
• Familiarity with NGS preferred
• Experience with achieving & maintaining regulatory compliance (e.g. GLP / GCP, CLIA, CAP)
• Strong analytical skills, problem-solving ability, and innovation aptitude required
• Must be willing to discover and learn new software and technology applications quickly
• Must have strong attention to detail and multi-tasking skills
• Excellent interpersonal skills and ability to effectively work across a multidisciplinary team

Desired Personal Traits

• You want to make an impact on humankind
• You prioritize “We” over “I”
• You enjoy getting things done – with super high quality
• You collaborate effectively with people of diverse backgrounds and cultures
• You have superior skills and experience, and constantly strive to be world-class in what you do
• You constantly challenge your own assumptions, pushing for continuous improvement
• You have a growth mindset
• You take pride in owning crucial tasks and successfully executing them
• You make decisions that favor the company, not yourself or your team
• You are candid, authentic and transparent