Director, Quality Assurance

Available locations: Pittsburgh, PA; or Duluth, GA.

Responsible for managing and overseeing the Quality and Compliance for the global Genomics Laboratories.  This person is the leader responsible for the Quality Assurance and Compliance function of the Laboratories, ensuring compliance to applicable regulations; Service Laboratories (CLIA/ CAP/ ISO, State level licenses). Reporting to this role are the Quality leads at each of our clients’ Genomics Laboratories locations (Pittsburgh, PA; Branford, CT; Chengdu, China; Taicang, China; Chennai, India; Kuala Lumpur, Malaysia and Sollentuna, Sweden).

This position reports to the VP and Chief Scientific Officer of Genomics. This position is based out of Pittsburgh.

Its main goal is to partner with Senior Management to maintain the quality management system components necessary to successfully maintain the Genomics laboratory services in good compliance standing.

• Manage, mentor and coach regulatory and service lab staff on CLIA, CAP, NYSDOH, ISO regulations for laboratories.
• Coordinate and lead corporate compliance as applicable to the laboratories
• Work with operation leadership to manage and provide vision and leadership to the quality organizations at all of the lab services locations.
• Serve as Data Protection Officer (DPO) ensuring compliance with GDPR and similar data and client privacy regulations.
• Provide and facilitate communication between the lab services quality organization and cross-functional teams to ensure quality and compliance objectives are met.
• Establish and drive quality initiatives for all lab services organizations and where possible create consistent practices among all labs.
• Manage routine QMR process, and support Diagnostics BE QMR process
• In conjunction with the Diagnostics BE Regulatory department, work to facilitate domestic and international regulatory requirements
• Work with sites to prepare for and participate in inspections and audits.
• Set quality objectives and metrics for labs and assist with achieving goals.
• Monitor emerging regulations or market expansion regulations that affect lab functions and work with sites to remain / gain compliance with those regulations.
• Collect and analyze data required by regulatory agencies and by internal requirements.
• Ensure each site has an effective training program and maintains compliance with regulations
• Perform internal audits of lab services sites as well as customer audits as necessary.
• Ensure sites maintain and perform to an internal audit schedule and assist with corrective actions as necessary.
• Respond to and maintain oversight of audit finding remediation
• As needed, apply continuous improvement principles for system optimization
• Monitor performance and progress against documented objectives

Basic Qualifications:

• Authorization to work in the US for any employer without requiring further sponsorship.
• Masters or Bachelor’s degree in Biological Sciences or related disciplines
• Minimum of eight years of clinical laboratory quality and compliance experience with an understanding of laboratory techniques such as DNA Sequencing in a commercial, academic, or government laboratory.

Preferred Qualifications:

• Certified in one or more quality-related disciplines, e.g., ASCP
• Detail oriented, highly organized, with excellent verbal and written communication skills.
• Ability to work independently under pressure of deadlines and a fast paced, high throughput team environment.
• Strong project management skills related to submission of validation documentation
• Excellent interpersonal skills and ability to work collaboratively with individuals at all levels of the organization.
• Experience leading and managing a diverse team of individuals with a proven track record of successful outcomes.
• Acts with honesty, integrity and a strong code of ethics at all times.

Women and Minorities are encouraged to apply.