Donor Services Laboratory is a comprehensive, highly accredited clinical reference laboratory serving the human transplantation and biomedical industries. Owned by industry veterans, gives DSL deep insight into the true needs of the transplant community and firsthand knowledge of what is on the horizon for transplant medicine.
With years of experience in clinical and donor testing, the professionals at DSL provide a customer-centric concierge approach to deliver what our customers expect. We understand what is at stake with every sample DSL receives. As a result, our customers can make reliable and informed decisions to ensure that every donation provides the greatest benefit. Being a partner with our clients, we are here to assist them with the lives of those they impact every day.
Headquartered in Las Vegas, Nevada, with a satellite facility in Tampa, Florida, DSL will be flexible to our client’s needs, creating a single-source solution for transplant-related testing services.
DSL offers state-of-the-art FDA-licensed, approved, or cleared equipment and testing kits to provide the individual service, support, and attention that our clients need and deserve.
Position Scope
The Director of Quality and Regulatory Affairs is a highly collaborative, influential, and experienced senior leader responsible for providing overall regulatory compliance leadership for the laboratory. This position must work closely with the entire team and all levels of employees. Plans and implements the Quality Management Program based on FDA 21 CFR 820 to meet and exceed regulatory requirements for CLIA, FDA, TGA, ISO, CAP, AATB, AABB, GHA, and UNOS. Responsibilities include management of the QMS and associated policies and procedures, submission of regulatory filings, development of strategies for continuous improvement and timelines and acts as a liaison for regulatory and accreditation agencies including CLIA, FDA, TGA, ISO, CAP, AATB, AABB, GHA, and UNOS. Monitors regulatory compliance across the organization to ensure audit readiness. The Directory of Quality and Regulatory Affairs leads continuous improvement activities and promotes a culture of quality and process improvement along with the vision and mission of the organization.
Job Duties
The following are essential functions and basic job duties that an employee must be able to perform, with or without reasonable accommodations.
Support of Company's mission, vision and values; adheres to its policies and procedures in carrying out the responsibilities of this position
Builds and develops the Quality Management System
Oversee the preparation and submission of regulatory documents
Manage regulatory submissions and interactions with regulatory authorities
Manage the Quality Management System including the occurrence reporting process, controlled document process, audit process, and process improvement initiative
Oversees staff and management training on regulatory and quality principles, laboratory safety program, and other topics as needed
Develop performance-based metrics to measure efficiency of the quality system
Prepare reports for management review oversight
Supervises Quality staff
Indirectly supervises and guides the on-site laboratory quality and safety officers
Facilitate and lead the team through all aspects of process improvement efforts
Review, document and report quality events or non-complying occurrences, perform root cause analysis and develop corrective and preventative action
Perform internal audits to ensure inspection readiness with the company systems and processes
Lead and participate in internal and external audits to assess compliance with regulatory requirements
Stay current with accreditation and certification regulations
Provide oversight on corrective and preventative actions
Accountable for the achievements and departmental goals and initiatives
Develop, implement and maintain controlled procedures, policies, protocols, and manuals
Oversees the maintenance of document control to monitor document review, editing and archival
Proactively manage issues, identify continuous improvement opportunities, and create action plans to execute.
Acts as an organization process champion to train, facilitate and lead teams through all aspects of process improvement efforts
Serves as a thought partner and collaborator with laboratory operations
Stay up-to-date with changes in regulations and guidelines to ensure compliance.
Note: This job description is not intended to be all-inclusive. The employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Qualifications
The following identifies the education, training and experience required to perform essential functions of the job.
Education & Certifications
Required: Bachelor’s degree in Laboratory Science, Statistics, Business Administration, or other applicable field of study
Preferred: Graduate level education or training
Highly Preferred: Quality certification such as: ASQ CQA, CMQ, Six Sigma Green Belt/Black Belt
Experience, Skills, and Abilities
Required: 5 years of experience working in a laboratory, GMP, or health care facility in quality, regulatory administration or QA/QC
Required: Experience with controlled document systems
Required: 3 + years of managerial experience
Highly Preferred: 3+ years of quality and regulatory affairs management
Highly Preferred: Experience working in an FDA, AATB, EBAA, ISO, HCT/P facility
Highly Preferred: In-depth knowledge of FDA regulations and guidelines
Highly Preferred: Experience working for a start-up organization
Strong project management skills, including the ability to prioritize tasks and meet deadlines.
Ability to lead, coach, and develop staff
Highly organized with excellent attention to detail
Ability to analyze data trends and meet deadlines
Interest in working as part of a small and growing company, with awareness about the opportunities and challenges that come with a highly adaptive environment
Comfort with ambiguity and ability to navigate uncertainty
Ability to retain confidential information
Exceptional verbal and written communication skills
Ability to present a professional image to management, staff, clients, and regulatory agencies
Independent critical thinking and creative problem-solving skills
Ability to interact effectively with all levels within the organization to influence participation in quality and process improvement related activities
Proficient in Microsoft Excel, and Word, and LIMS
Physical Demands
The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of the job.
Ability to travel to facilities in the US on a regular basis for quality oversight
Ability to function in a normal office environment
Ability to attend quality and industry meetings and conferences
Donor Services Laboratory is a comprehensive, highly accredited clinical reference laboratory serving the human transplantation and biomedical industries. Owned by industry veterans, gives DSL deep insight into the true needs of the transplant community and firsthand knowledge of what is on the horizon for transplant medicine.
With years of experience in clinical and donor testing, the professionals at DSL provide a customer-centric concierge approach to deliver what our customers expect. We understand what is at stake with every sample DSL receives. As a result, our customers can make reliable and informed decisions to ensure that every donation provides the greatest benefit. Being a partner with our clients, we are here to assist them with the lives of those they impact every day.
Headquartered in Las Vegas, Nevada, with a satellite facility in Tampa, Florida, DSL will be flexible to our client’s needs, creating a single-source solution for transplant-related testing services.
DSL offers state-of-the-art FDA-licensed, approved, or cleared equipment and testing kits to provide the individual service, support, and attention that our clients need and deserve.