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Validation Quality Manager

2 months ago

Elkton, Maryland, United States Terumo Full time

Terumo Medical Corporation (TMC) is at the forefront of developing, producing, and distributing a comprehensive portfolio of high-quality medical devices tailored for a wide array of applications within the healthcare sector. TMC prioritizes delivering exceptional products, along with training and educational initiatives that yield significant economic benefits, enhance clinical outcomes, and improve patients' quality of life. As a subsidiary of Tokyo-based Terumo Corporation, a global leader in medical device manufacturing with over $6 billion in sales and a workforce exceeding 30,000 across more than 160 countries, TMC operates with a commitment to excellence.

At Terumo, we envision a promising future for all our employees. We strive to create enduring change, maximize our impact, and achieve superior outcomes for today and future generations. We are dedicated to fostering personal growth, encouraging you to take charge of your career trajectory by enhancing your skills. We invite you to be innovative, think creatively, and contribute to the next advancements in quality healthcare. You will collaborate with a diverse, respectful, and resilient team of professionals and leaders globally, working in unison to accomplish more than you ever imagined, delivering meaningful solutions for patients.

Join us in shaping the future of healthcare

Advancing healthcare with heart

Position Overview

  • Validation System: Design, develop, and enhance the validation quality system in alignment with relevant regulations and industry best practices.
    • Create standard operating procedures and templates for validation activities, including installation qualifications (IQ), operational qualifications (OQ), process qualifications (PQ), cleaning validations, and process validations (PV).
    • Establish and uphold a Validation Master Plan (VMP) for all TMC manufacturing sites, incorporating risk-based revalidation requirements.
    • Oversee the execution and metrics related to the revalidation of existing Terumo products.
    • Develop and deliver validation training across the organization.
    • Continuously refine validation processes based on regulatory updates, industry best practices, lessons learned, and feedback from the Terumo Corporation Validation Center of Excellence.
    • Enhance Test Method Validation procedures.
  • Validation Strategy: Collaborate with project and quality engineers to formulate validation strategies ensuring products and processes are validated appropriately.
    • Develop validation strategies based on risk assessments, product specifications, and process controls, encompassing IQ, OQ, PQ, PV, and cleaning validations.
    • Review qualification and validation protocols to ensure adherence to validation strategies, regulations, and best practices.
    • Support investigations, impact assessments, and corrective actions for validation and re-validation non-conformances.
    • Ensure proper linkage of process qualifications to the process monitoring and control plan.
  • Change Management: Consult on change management initiatives to ensure validation strategies address all critical parameters.
    • As a member of the Change Review Board, evaluate change requests to confirm that appropriate validation requirements are identified.
    • Guide change leaders on validation requirements related to changes.
    • Ensure rationales for validation strategies are documented within change documentation.
    • Support validation lifecycle management through the change management process.
Key Responsibilities
  • Statistical Methods: Provide guidance on statistical analysis methods and applications across the organization.
  • Assist TMC sites and subsidiaries with compliance and quality system challenges, collaborating with site personnel to identify root causes and corrective action plans to enhance the quality system.
  • Conduct due diligence for acquisition projects, highlighting validation-related risks to executive leadership and supporting the integration of validation processes.
  • Manage a team of direct reports, contractors, and/or consultants as necessary.
  • Mentor and train engineers on validation principles and methodologies.
  • Promote a proactive and preventive quality systems culture throughout the organization.
  • Stay informed about global medical device regulations related to quality systems and assist in facilitating internal and third-party audits as required.
  • Set, communicate, and evaluate team goals and objectives for ongoing improvement of the quality system's efficiency and effectiveness.
  • Perform other job-related duties as assigned.
Qualifications and Skills
  • B.S. degree or equivalent in a Scientific or Engineering discipline is required.
  • A minimum of 8 years of overall experience, with at least 4 years in medical devices/diagnostics, pharmaceuticals, or other regulated industries focusing on quality system responsibilities.
  • Preferred: Minimum of 5 years of managerial experience.

Terumo is committed to providing equal employment opportunities to all employees and applicants without regard to race, creed, color, national origin, age, ancestry, nationality, marital status, sex, gender identity, disability status, or any other category protected by law. We value diversity and prohibit discrimination or harassment based on any legally protected class in all aspects of employment.