Director, Quality Systems - Molecular Genomics & Oncology

at  Quest Diagnostics

Overview:
The Director, Quality Systems is responsible for leading the development, design, implementation, and maintenance of the Quality Management System to support product development and commercialization of Molecular Genomics & Oncology (MGO) with the goal of maximizing efficiency, effectiveness, and compliance with all appropriate quality regulations and standards of practice.
The role will need to ensure deep understanding of the R&D, Program and Project Management, Operations (Clinical lab, procurement), and Commercial strategy to maximize the competitive advantage of the GxP Quality Systems to drive performance improvements in alignment with MGO business needs and priorities.
This is not a role for which a cookie cutter/lift and shift mindset will fit, but rather where the Quality Systems leader can bring their expertise to build an outcomes-risk based quality systems infrastructure that fully enables the business and is able to smoothly adapt as the objectives evolve, while delivering the highest degree of quality along the development continuum unique to Molecular Genomics & Oncology (MGO) technology and programs.

Responsibilities:

• Design and development of programs to drive a risk-based and outcomes focused Quality Management System, supporting compatibility and integration of quality processes driven core principles, Data Integrity, Scientific Integrity, Patient safety and Product Integrity.
• Define process excellence and an integrated process architecture to account for all the end-to-end processes required to facilitate medical device across development, through regulatory submissions and approvals, registration, and into full commercialization.
• Drives implementation plan of controlled document management, review and approve various GxP documentation, including master batch records, specifications, methods, and validation protocols, equipment qualification documents. (e.g., process, method, etc.), Change control management.
• Oversees the day-to-day administration of the QMS, particularly major sub-systems including Document Management, Training Management, CAPA, Change Management, Deviations, validation management, Complaint Handling, and Audit Management.
• Drive implementation of product Design and development documentation structure including establishing a process for approving DHF, validation protocols and risk management files
• Drive cross-functional assessment of the document management maturity and defining a new vision for a GxP document landscape ensuring it is effective and simplified.
• Support implementation of software for GxP systems, including contributing to configuration requirements, test and validation execution, and development of procedures/work instructions.
• A second key aspect of process excellence will require assessing the document management maturity and defining a new vision for a GxP document landscape ensuring it is effective and simplified.
• Drive the development of Governance related processes (e.g. quality polices, manuals, etc.), documentation, including metrics, dashboards, readouts in support of Quality Oversight, including an overall picture of the health of the Quality management System.
• Manage the organization and layout of the warehouse to maximize space utilization and ease of access, yet maintain in compliance with FDA, ISO, and CAP/CLIA regulations and safety standards.
• Support strategy development at and drives execution of a pipeline of continuous improvement initiatives to drive simplification, reliability, and overall effectiveness of Quality processes.
• Other duties as assigned.

Qualifications:

REQUIRED WORK EXPERIENCE:

• A minimum of 8-10 years’ preferably implementing and overseeing QMS within a broader quality organization for a life sciences organization supporting development programs
• Experience with implementation of electronic quality management systems is desired, Veeva experience preferred.
• Experience developing and/or managing GxP quality systems including document control, change control, CAPA, and/or deviations.
• Experience in project management and continuous improvement methodologies (e.g. Six Sigma, Lean, Total Quality Management) preferred.
• ISO 13485: 2003/2016 QMS Lead Auditor
• Certified Quality Auditor

PHYSICAL AND MENTAL REQUIREMENTS:

• Strong attention to detail for thorough analysis of quality data and documentation.
• Excellent problem-solving skits to identify and address quality issues effectively.
• Ability to work under pressure and meet deadlines, maintaining accuracy.
• Strong communication skills to collaborate with various teams and present finding effectively.

KNOWLEDGE:

• Broad based technical knowledge and skills in diverse areas of business such as Quality Engineering, Quality Assurance, Quality Systems, GMP Operations as well as a good working knowledge of related functions such as operations, supplier management, laboratory operations and product development.
• Advanced knowledge and experience in one or more of the following: Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Quality Control, Quality Assurance, Quality Compliance and/or Quality Audits.
• Advanced knowledge and experience authoring Policies, Standard Operating Procedures (SOPs), Work Instructions and technical documents.
• Working knowledge of both FDA 21CFR Part 820 Quality Systems Regulations, ISO13485 standards, and CLIA, CAP, NYS requirements
• Demonstrated knowledge of business impact of compliance issues and risk management.

SKILLS:

• Strategic, influential leader with ability to drive quality initiatives, operational excellence, and continuous improvement across multiple functions.
• Ability to host / manage external Quality System inspections is required with a preference for experience gained with hosting FDA and other health authority inspections.
• Ability and willingness to roll up sleeves and engage to resolve day-to-day issues.

EDUCATION:

Bachelor’s Degree(Required)

• Design and development of programs to drive a risk-based and outcomes focused Quality Management System, supporting compatibility and integration of quality processes driven core principles, Data Integrity, Scientific Integrity, Patient safety and Product Integrity.
• Define process excellence and an integrated process architecture to account for all the end-to-end processes required to facilitate medical device across development, through regulatory submissions and approvals, registration, and into full commercialization.
• Drives implementation plan of controlled document management, review and approve various GxP documentation, including master batch records, specifications, methods, and validation protocols, equipment qualification documents. (e.g., process, method, etc.), Change control management.
• Oversees the day-to-day administration of the QMS, particularly major sub-systems including Document Management, Training Management, CAPA, Change Management, Deviations, validation management, Complaint Handling, and Audit Management.
• Drive implementation of product Design and development documentation structure including establishing a process for approving DHF, validation protocols and risk management files
• Drive cross-functional assessment of the document management maturity and defining a new vision for a GxP document landscape ensuring it is effective and simplified.
• Support implementation of software for GxP systems, including contributing to configuration requirements, test and validation execution, and development of procedures/work instructions.
• A second key aspect of process excellence will require assessing the document management maturity and defining a new vision for a GxP document landscape ensuring it is effective and simplified.
• Drive the development of Governance related processes (e.g. quality polices, manuals, etc.), documentation, including metrics, dashboards, readouts in support of Quality Oversight, including an overall picture of the health of the Quality management System.
• Manage the organization and layout of the warehouse to maximize space utilization and ease of access, yet maintain in compliance with FDA, ISO, and CAP/CLIA regulations and safety standards.
• Support strategy development at and drives execution of a pipeline of continuous improvement initiatives to drive simplification, reliability, and overall effectiveness of Quality processes.
• Other duties as assigned