ERT

Vice President, Quality Management

Job Location US-PA-Philadelphia | US
Shift
Regular
Type
Regular Full-Time

Overview

ERT is looking to hire a Vice President, Quality Management, to oversee Quality Management activities globally, ensuring corporate compliance with internal processes/procedures, regulatory authorities, medical device standards and industry expectations. In this role you will ensure adequate quality monitoring procedures are implemented to proactively identify and resolve quality issues. You will continually work to improve the effectiveness of QMS through the effective application of quality policies, objectives, audit results, analyses of data, and corrective/preventive actions.  You will strategically engage with Regulators around the world to ensure ERT has a voice in evolving GXP regulations that affect our customers and the science of endpoint collection

Responsibilities

  1. Serves as the Executive Management appointed Head of Quality Management whose responsibilities include the establishment, implementation, and maintenance of the Quality Management System in accordance with ISO standards.

 

  1. Develop and manage corporate Quality Management program to assure compliance of ERT business processes with respect to applicable regulatory requirements (specifically GxP, 21 CFR Part 11, ECG, ePRO, Imaging, Respiratory, and other endpoint data collection standards, ISO standards, and medical device regulations).

 

  1. Strategically lead the engagement with various Regulators around the world as well as working groups (like the EU GCP Working group) to ensure that ERT provides thought leadership in the evolving regulations as well as builds working relationships with various regulatory agencies.

 

  1. Management of the Acceptance Validation team. This includes responsibility for the development of Test Strategies, Master Plans, Acceptance Validation Protocols and creation of test scripts and associated datasets. The organization and oversight of test execution and deviation reporting and responsibility for the generation and distribution of Acceptance Validation Summary reports for ERT core technologies. Ensure that ERT remains in compliance with evolving regulatory standards around computerized system validation.

 

  1. Management of the Training Coordination team. This includes responsibility for managing employee-training programs, employee-training files and related documentation for the ERT organization. Assisting with the development and managing the implementation of assigned training to meet the job code requirements.

 

  1. Serve as the Official Correspondent & Owner/Operator for ERT medical device management and registration with U.S. Food & Drug Administration & other global regulatory agencies.

 

  1. Management of the GCP Compliance team that serves as the primary contact within ERT for the preparation, conduct and follow up of Sponsor and domestic and foreign Regulatory Agency audits.

 

  1. Manage and perform corporate audits and assist in all corporate functions.

 

  1. Define annual audit schedules and oversee the conduct of ongoing audits of the following to assess compliance with ERT SOPs, Sponsor requirements, and regulatory authorities.
    • ISO Standards
    • Internal processes (GxP)
    • Project specific processes/requirements
    • Computer Systems
    • Vendors

 

  1. Review all Audit Plans and Audit Report. Maintain the status of all audit findings in the Quality Management database and ensure prompt resolution.

 

  1. Perform tracking/trending analysis of audit findings and assist operations, product management, R&D, and other functions in the implementation of corrective action plans, as appropriate.

 

  1. Supervise Technical Quality staff in the development, distribution, and tracking of monthly, and quarterly statistical analysis and reporting of CSS/Cardiology Inter/Intra Variability programs and as necessary for other parts of the business as needed.

 

  1. Develop and ensure maintenance/management of the following quality documents:
  • Quality Management System Documentation (Quality Manual, Local Quality Requirements)
  • ERT Corporate Policies
  • ERT Standard Operating Procedures
  • External, Internal, Vendor Audit Database (Quality Management database)
  • Annual Audit Schedules

 

  1. Perform the Quality Management review for all SOPs as well as manage the annual SOP review and update process through the controlled document management application.

 

  1. Provide leadership and direction in the development and execution of integration strategies for an effective and smooth transition for current and future ERT affiliates.. Drive integration planning by outlining the organizational approach, tools, and processes to be used with the various workstreams,

 

  1. Partner with other business executives to assure quality in ERT’s design systems and offerings. Support R&D and Product Development teams and verify/establish traceability between ERT’s product development SOPs and processes and compliance with regulatory requirements.

 

 

OTHER DUTIES AND RESPONSIBILITIES:

 

  1. Serve as the liaison with Sponsors and other external parties with regard to quality issues.
  2. Provide consulting services to contracted external sources as required.
  3. Ensure the definition and delivery of corporate Quality Management trainings as well as annual Quality Training courses (e.g. Good Quality Practices, etc.) as necessary
  4. Conduct ongoing internal meetings to monitor internal quality programs and issues.
  5. Provide management summary reports of Quality Management activities.
  6. Perform other duties, assignments, or special projects as time and/or circumstances necessitate.

 

 

The duties and responsibilities listed in this job description represent the major responsibilities of the position.  Other duties and responsibilities may be assigned, as required.  This job description and any attachments do not constitute or represent a contract.

Qualifications

  1. Bachelors Degree required.
  2. Minimum 7 years Management/Supervisory experience.
  3. 10-15 years Quality Management experience (QA/RA) or related field.
  4. Knowledge of GxP Standards, ISO Standards and applicable regulatory authorities
  5. Excellent organizational and communication skills
  6. Detail oriented
  7. Strategic Focus and Ability to motivate and lead a large organization
  8. Excellent computer skills including database management/design and proficiency in Microsoft Office Suite.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Connect With Us!

Not ready to apply? Connect with us for general consideration.