ESSENTIAL DUTIES AND RESPONSIBILITIES
o Maintains and improves the Agendia QMS [compliance with FDA, IVDR, CLIA, ISO, etc.].
o Ensures applicable standards and regulations pertinent to Agendia are effectively implemented and acts as an advisor to all managers.
o Leads development of regulatory submissions.
o Provides support to currently marketed products as necessary: labeling, product changes/documentation.
o Coordinates initiatives to support quality systems, IVDR and continuous improvement efforts.
o Collaborates with management team in development, and execution of goals, objectives and projects.
o Leads document control, including adherence to Good Documentation Practices and storage of records, for compliance related documentation.
o Manages the Quality System training program by sending notifications of training required and training records.
o Reviews batch records and other QMS documentation as needed.
o Manages at least one of the following processes with minimal supervision:
· Complaint Handling – investigation, escalation and reporting requirements as needed.
· Corrective and Preventive Action (CAPA) – tracking, trending of approved CAPAs, and driving timely/appropriate completion of activities.
· Deviations – tracking, trending, and driving timely/appropriate closure.
· Nonconformances – tracking, trending, and timely/appropriate closure.
· Internal Audits – conducting internal audits and/or serving as a Subject Matter Expert (SME); monitoring the progress of any required actions and their effectiveness in improving quality.
· Supplier Management – as needed.
· External Audits – as needed.
· Training – as needed on Quality and/or Regulatory topics.
o Leads obtaining and/or renewing of domestic and international certifications and registrations.
o Creates and maintains Technical Files.
o Facilitates design and risk management activities.
o Reviews regulatory affairs documents and compiles documentation for regulatory agencies and Notified Body.
o Develops and maintains a variety of metrics pertaining to QMS activities as assigned, including collecting/presenting data for Management Review and Quality Management Program reviews.
o Facilitates meetings related to QMS and Regulatory activities.
o Leads change orders/process improvements with respect to QMS procedures with direction from management.
o Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
o Develops, supports and promotes company-wide compliance programs.
o Mentors, trains and coaches new personnel as required.
o Performs other related duties as required or assigned.
The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.
KEY CONTACTS
Internal
o All levels of the organization and works especially close with the laboratory operations and department directors in R&D, Product Support, Clinical, Marketing, and IT. This position has interactions with all departments company wide.
External
o Vendors and regulatory agencies, such as the FDA, ISO Notified Bodies other global regulatory agents.
o Experience with State Clinical Boards and/or the College of American Pathologists (CAP), is preferred.
EDUCATION AND EXPERIENCE REQUIREMENTS
EDUCATION
o Bachelor’s Degree in Molecular Biology or related field.
EXPERIENCE
o In vitro diagnostic or molecular reagent quality assurance, document control, configuration management, supply chain, operations, and/or quality departments within a regulated environment, preferred.
o Minimum of 5 years of industry experience; in vitro diagnostic or molecular reagent quality assurance or regulatory affairs preferred.
KNOWLEDGE, SKILLS AND ABILITIES (KSA’S)
o Advanced understanding and applying quality system regulations and standards, including GDP, CLIA, CAP, ISO 13485 and/or 21 CFR Part 820.
o Excellent critical thinking, problem solving and analytical skills.
o Effective interpersonal and communication skills and capable of supporting cross-functional project goals.
o Advanced experience in MS Word, Excel, and PowerPoint required.
o Advanced experience with delivering training material to groups.
o Must be team oriented and have effective communication skills to work as part of a team.
o Advanced experience in supporting and guiding ISO/FDA inspections is strongly preferred.
o Proven experience with official (external) training in auditing and in CAPA’s (Corrective and Preventive Actions) preferred.
o Molecular biology or diagnostics experience preferred.
o ASQ Certification in CBA or CQA desired.
o RAPS Certification desired.
BEHAVIOURAL COMPETENCIES/DESIRED SKILLS
o Able to prioritize and plan work activities, use time efficiently and develop realistic action plans with detailed follow through.
o Ability to stay on task with little supervision.
o Willing to make decisions, exhibit sound and accurate judgment, and make timely decisions for the result with limited direction.
o Ability to learn and comprehend new technical skills and knowledge.
o Must have the ability to work as a team player within all levels of the company.
o Ability to effectively communicate with individuals and groups across interdisciplinary roles.
o Ability to read and interpret documents.
o Attention to detail.
o Proficient with MS Office, including Word, Excel and PowerPoint programs.
o Takes initiative.
o Flexibility.
o Can do-attitude.
· PRIVACY NOTICE: To review the California privacy notice, click here: https://agendia.com/privacy-policy/
WORKING ENVIRONMENT
Establishes ADA (Americans with Disabilities Act) requirements
ENVIRONMENT/SAFETY/WORK CONDITIONS
Working conditions (inside or outside the office).
o General office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
o Regularly walks, stands, and sits.
o Regularly works on a computer for approximately 6-8 hours a day.
o Must be able to read and understand complex directions.
TRAVEL
o <10% Travel
OTHER DUTIES
Other duties as required.