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Sr Dir, Quality Assurance - Lab Operations

  • Morrisville, North Carolina, United States
  • Full Time

About the Job

The Senior Director, Quality Assurance - Laboratory Operations is a position within the Quality Assurance department which is responsible for ensuring quality and compliance to applicable regulations (including CAP, CLIA, NYSDOH, and ISO 15189) for FMI’s comprehensive genomic profiling laboratory. This Senior Director is responsible for leading the Quality Assurance (QA) function within the FMI Research Triangle Park laboratory. This role also supports and manages the quality system procedures and processes related to the laboratory operation and provides coaching, mentoring and guidance on complying with applicable regulations, standards and license requirements. The incumbent partners with senior management and laboratory site management to maintain quality management system components necessary to successfully maintain good compliance standing for FMI laboratory operations. 

Key Responsibilities

• Manage FDA Pre-market Application Inspection (PAI) hosted at the laboratory.

• Establish the quality assurance organization's vision across all sites, consistent with FMI's overall vision, short- and long- term objectives.

• Conduct high level planning for the quality assurance function at Research Triangle Park.

• Direct, teach and coach laboratory staff on CLIA, CAP, NYSDOH, and ISO 15189 regulations.

• Provide and facilitate communication between the laboratory quality organization and cross-functional teams to ensure quality and compliance objectives are met.

• Establish and drive quality initiatives for the lab organization and where possible create consistent practices amongst all labs.

• Set quality objectives and metrics for the labs and assist with achieving goals .

• Monitor emerging regulations or market expansion regulations that affect lab functions and work with sites to maintain and gain compliance with those regulations.

• As needed, apply continuous improvement principals for system optimization.

• Provide high-level review and feedback on validation plans and reports.

• Manage a team of direct reports and provide applicable guidance, coaching, hiring and evaluation for quality assurance.

• Direct and delegate quality assurance workflows, tasks and special projects.

• Ensure proper management of deviations.

• Represent the quality assurance function of FMI to external audiences and partnerships.

• Prepare the schedule for internal audits and liaise with appropriate stakeholders for audit preparedness.

• Respond and maintain oversight of audit finding remediation.

• Maintain initiatives to ensure that record keeping under FDA/GLP/CAP/CLIA/15189/NYSDOH requirements are attributable, legible, contemporaneous, original and above all, accurate.

• Ensure that laboratory equipment standards are poperly maintained, cleaned and inspected on a routine basis per Standard Operating Procedures (SOPs).

• Oversee Management of employee training files, and steps associated, including: Review credentials to ensure compliance; and manage training matrix.

• Participate in budget preparation for the Quality Assurance function.

• Maintain availability to wider FMI to provide quality guidance and expertise as needed.

• Travel domestically up to 30%.

• Other duties pertinent to quality assurance as occasionally assigned.

Qualifications

Basic Qualifications

• One of the following two education and experience combinations:

·   (1) Bachelor's Degree and 8+ years of quality assurance experience, OR

·   (2) Master's Degree and 6+ years of quality assurance experience

• 3+ years of experience managing direct reports

Preferred Qualifications

• 12+ years of quality assurance experience, 8+ years of which was in laboratory quality assurance

• 10+ years of experience in the biotechnology, pharmaceutical, diagnostic, or healthcare industries

• 5+ years of experience managing direct reports

• In depth working knowledge of CLIA, CAP, NYSDOH and ISO 15189 regulations along with FDA regulations for In-Vitro Diagnostics.

• Familiarity with GMP, 21 CFR Part 11, FDA GMP

• Scientific background in molecular biology and/or Next Generation Sequencing

• Prior experience:

·   or familiarity with companion diagnostics or clinical lab operations

·   with managing QA activities across multiple quality system requirements (operating under both FDA CFR Part 820 and CLIA/CAP)

·   analyzing and problem solving complex laboratory quality assurance matters

• History of:

·   a process-oriented, flexible approach

·   consistently delivering results on schedule in a fast-paced, dynamic environment

• Strong interpersonal skills that include clear and concise written and oral communication skills, as well as collaborative problem solving

• Superior attention to detail, prioritization, and organizational skills

• Demonstrated ability to successfully managing multiple concurrent initiatives and maintaining one’s own workflow

• Demonstrated ability to work well under pressure while maintaining a professional demeanor

• Ability to travel up to 30% for work

• Understanding of HIPAA and importance of patient data privacy

• Agreement to maintain confidentiality of business and proprietary information

• Commitment to reflect FMI’s values: passion, patients, innovation and collaboration

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Internal applicants, please use your FMI email address.

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