Director Quality &
Regulatory Affairs (US)

 

Your job in a nutshell

The Director of Quality and Regulatory Affairs, US will be responsible to develop and maintain the Quality Management System (QMS) infrastructure to comply with CLIA, CAP, CDPH, and other state licensing requirements in support of our clinical laboratory. This position will help to oversee and prepare the QMS in all areas of the laboratory for audit readiness and ensure quality of services. This position will be responsible for oversight of certification and accreditation activities including but not limited to compliance with CLIA, CAP, California, other state licenses, and any other applicable accrediting/certifying agency. This position will report to the CEO, but works closely with the Lab Director, the Associate Director of Lab Operations, supervisory and testing personnel. The position will also work in collaboration with scientists developing assays, bioinformatics experts, software engineers, and quality personnel located in Rotterdam, The Netherlands.

The Director of Quality and Regulatory Affairs, US is responsible for facilitating the overall administration of the Quality Management System and ensuring compliance with applicable laboratory regulations. This position will assist in the implementation of eQMS software to support laboratory operations and regulatory compliance. The nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multi-task and be flexible with tasks and schedules, and the ability to work both independently and in a team environment.

Together we ensure the validation and implementation of clinically relevant scientific discoveries into reliable medical diagnostic assays for diagnosis, prognosis and drug effectiveness prediction that will ultimately contribute to improved patient care. 

 

Tasks & Responsibilities:

  • Help to ensure that company priorities, regulatory/accreditation requirements and timelines are met

  • Work with cross-functional core teams to ensure that regulatory and business requirements are fulfilled

  • Review policies, SOPs and validations to ensure they meet regulatory requirements

  • Maintain all Clinical Laboratory regulatory licenses for the facility and ensure renewal of licenses as required. Lead the coordination of certification and accreditation activities including compliance with CLIA, CAP, state licensing, etc.

  • Ensures proper evaluation, timeliness and completeness of investigations, root cause analysis as well as corrective and preventive actions (CAPA)

  • Assist with nonconforming event management system including tracking timely resolution of events through corrective/preventive action

  • Assist with training of personnel on Quality System policy and procedures

  • Chairs Quality Committee meetings

  • Manage quality metrics collection, reporting and analysis, and presentation

  • Identify, track and carry out Quality Improvement initiatives

  • Perform internal and external vendor qualification audits

  • Collaborate on the implementation of eQMS software modules to include document control, nonconforming event management, and change control

  • Oversee the document control system and ensure compliance with organizational policy/regulatory requirements

  • Ensure compliance with current applicable regulatory requirements

  • Help to foster a culture of compliance and quality

  • Serve as resource for lab-related Quality and Regulatory matters

 

Minimum Qualifications (Must Have)

  • Minimum 5 years Quality Management experience in the clinical laboratory environment

  • Experience working in CLIA-certified and CAP-accredited laboratory settings and operations

  • Possess working knowledge of applicable local, state and federal clinical laboratory regulations

  • The ability to work beyond standard business hours when needed

 

Preferred Qualifications

  • Experience in a start-up environment

  • Dynamic individual with the ability to communicate and engage others

  • Self-Starter

  • Molecular/genetics laboratory and/or bioinformatics experience strongly preferred

  • Experience implementing compliance/Quality Management System software highly preferred

  • Experience with FDA, NYSDOH and/or clinical trial regulations would be a plus

  • Experience managing HIPAA compliance

 

We offer

  • a full-time position, a market competitive salary and market competitive secondary conditions of employment.

  • opportunities for personal growth.

  • the best of two worlds: a career in life sciences at an innovative biotech company with the emphasis on clinical diagnostics in close collaboration with an academic environment.

  • the ability to serve society with science based solutions.

  • Competitive 401K matching program and comprehensive health insurance coverage

 

At SkylineDx

we live to make a difference. It is our mission to improve a patient’s quality of life by enabling them to benefit from personal insights at the genomic level of their disease. That means we are continuously innovating the world of gene signature-based diagnostic testing. That also means we have a unique blend of characteristics. We have our soft side. Our culture is oftentimes described as familial, warm, loyal and highly engaged. We have our rational side where exact sciences are driving our mission. And when needed our passionate side surfaces to clear the way so we can serve society with science based solutions.

 

Our quotes

#serviceisjoy

#valueformoney

#playtogethertowin

#amazingthingshappen

#cogitoergosum

#itsyourparty

 

Do apply!

Send your resume and motivation letter to Deborah Wigmans (HR) at info@skylinedx.com. If you have questions or want more information, don’t hesitate to contact us. You’ll find the contact details on our website. We will make sure it lands on the right desk!