Senior Manager of Quality Management Systems

Primary FunctionThe Senior Manager of Quality Management Systems will lead the implementation and management of a quality management system for the company including responsibility for maintaining compliance with FDA related requirements. This position will work closely with the Director of Quality Management Systems and guide a team of individuals to oversee the implementation of policies and procedures to ensure adherence to production quality standards. Additional primary responsibilities include identification of deficiencies or gaps in laboratory processes, developing solutions to ensure adequate and robust quality processes using root cause analysis, and optimizing workflows to comply with existing and new regulatory requirements.

Essential Duties and Responsibilities:

* Oversee the development and maintenance of the Internal Quality System
* Ensure the timely and accurate reporting of adverse event reports to regulatory authorities and oversee investigations and any necessary corrective and preventive actions
* Provides guidance and required decisions in interpretation of quality and regulatory requirements to support company objectives
* Oversee the customer complaint process, including investigations, root cause analysis, and resolution of complaints in a timely and efficient manner
* Perform risk assessments and facilitate control plans to prevent/resolve issues
* Oversee and assist with documentation regarding procedures for process control, process improvement, testing, inspection and certification in the areas of quality control, quality assurance in accordance with the Clinical Laboratory Improvement Amendments (CLIA) regulations, CAP accreditation, FDA compliance, and/or specific state regulations
* Work closely with various departments and process owners to provide process analysis oversight to enforce requirements, meet regulations, and support continuous improvement
* Devise QMS review plans, lead in execution, validate report findings and recommendations
* Plans and conducts audits of clinical research activities to assess compliance with FDA and local regulations
* Manage and oversee the company's Non-Conformance (NC) and Corrective and Preventive Action (CAPA) programs to ensure that quality issues are effectively resolved and prevented from recurring
* Utilization of root cause analysis methods to improve departmental quality management systems
* Provide input to strategic decisions that affect the functional areas of responsibility across departments
* Ensure that all quality-related SOP/Training programs are effectively implemented and maintained for all employees involved in the design, manufacture, and distribution of products
* Work effectively on multiple projects simultaneously
* All other reasonable duties, as assigned.

Skills, Knowledge, Abilities:
Mental Abilities and Skills Requirements-

* Proficiency in MS Office programs, quality control applications, word processing, specifically Excel formula creation and editing
* Coordinate multiple projects/ assignments accurately, with special attention to detail at various stages of deployment
* Adapt to a constantly changing environment and the ability to work under tight deadlines
* Effectively communicate information to technical and non-technical audiences; ability to proactively communicate consistently, clearly, and honestly to ensure alignment to direction and goals
* Strong oral and written communication skills.
* Strong analytical, critical-thinking and team facilitation skills to collaborate with key stakeholders
* Strong organizational skills in planning and scoping of quantitative/qualitative projects

Knowledge Needed-

* Advanced knowledge of Quality Management Systems operations policies and procedures
* Understanding of safety protocols, occupational safety, and health rules and regulations
* Diverse knowledge of inspection and control methods, techniques, validations, and documentation
* Hands-on project management experience and Quality Review Board (QRB) knowledge
* Demonstrates exceptional understanding of Root Cause Analysis methodology
* Knowledge and experience working with web or cloud-based Quality Management System software using multiple modules in an interconnected closed-loop manner (e.g. Doc, Training, Supplier Qualification, Design Controls, N/Cs, CAPAs)
* Proficient understanding of Key Performance Indicators (KPI) with a Quality Management scope to reinforce continuous improvement processes
* Prior experience and knowledge of CLIA regulations and CAP requirements

Education and Certification:
Education/Experience Requirements-

* Bachelors of Science degree or a Master's of Science degree in related field and minimum 5 years of experience leading the development and / or management of a quality management system in a clinical laboratory environment.

Certifications-

* ISO, Six Sigma Black or Green Belt, ASQ, PMP, or other relevant certifications preferred.

Work Environment:
VANCOUVER OFFICE - Most work will be performed in an office. However, this position may require some traveling and working between locations. Workweeks usually consist of 40 hours.

Hazards:

* Work is performed in an office environment, full manual dexterity and visual acuity required. However, access to the laboratory may be necessary and therefore employee may be exposed to potential physical harm from hazardous chemicals, infectious diseases, blood-borne pathogens, toxic materials, toxic gases, electrical hazards, dangerous tools, and equipment.
* Hep B Vaccination provided at no cost to employee.

Molecular Testing Labs embrace diversity and is an Equal Opportunity Employer, and hire without regard to any individual's race, age, color, national origin, ancestry, disability, veteran status, religion, marital status or domestic partnership; pregnancy, childbirth or related medical conditions; other medical conditions or genetic characteristic; sexual orientation, gender, gender identity or transgender status; or any other basis protected by state, federal or local law, regulation or ordinance. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Molecular Testing Labs provides reasonable accommodation upon job seeker request in all steps of the employment process.