Manager, Validation

Date: Jul 5, 2024

Req ID: 3427

Location:

Elkton, MD, US

Company: Terumo Medical Corporation

Department: TIS Design Assurance/Quality Engineering

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

Job Summary

• Validation System: Design, develop, maintain, and continuously improve the validation quality system in accordance with applicable regulations & industry best practices.

• Develop standard operating procedures and associated templates for process validation activities including installation qualifications (IQ), operational qualifications (OQ), process qualifications (PQ), cleaning validations and process validations (PV).

• Establish and maintain a Validation Master Plan (VMP) for all TMC manufacturing facilities, including the requirements for risk-based revalidation.

• Oversee the execution and metrics associated with revalidation of existing Terumo products.

• Generate and conduct validation training across the organization.

• Continuously improve the validation processes based on regulation changes, industry best practices, lessons learned, and input from Terumo Corporation Validation Center of Excellence.

• Maintain and improve Test Method Validation procedures.

• Validation Strategy: Collaborate with project engineers and quality engineers to develop validation strategies to ensure the product and associated processes are appropriately validated.

• Develop a validation strategy for the product based on risk, product specifications, and process controls. Validation strategies shall include considerations for IQ, OQ, PQ, PV and cleaning validations.

• Review process qualification and validation protocols for projects to ensure compliance to the validation strategy, appropriate regulations, and best practices.

• Supports the investigation, impact assessment and corrective actions for all validation and re-validation non-conformances.

• Ensure appropriate linkage of process qualifications to the process monitoring and control plan.

• Change Management: Consult on change management projects to ensure the validation strategy encompasses all critical parameters.

• As a member of the Change Review Board, review change requests to ensure appropriate validation requirements have been identified.

• Provide guidance to change leaders on validation requirements for the change.

• Ensure appropriate rationales for validation strategies are included within the change documentation.

• Ensure change management process supports validation lifecycle management

Job Details/Responsibilities

• Statistical Methods: Provide organizational guidance and best practice with respect to statistical analysis methods and applications.

• Support TMC sites and subsidiaries on compliance and quality system related challenges. Work with site personnel to identify root cause and corrective action plans to improve the quality system. Drive corrective actions across the organization by utilizing continuous improvement techniques and providing guidance for specific processes including but not limited to test method validation, cleaning validation, and process validation.

• Conduct due diligence efforts for acquisition projects ensuring risks associated with validation are highlighted to executive leadership. Support the integration and remediation of validation processes as part of the integration projects.

• Manage a team of direct reports, contractors and/or consultants as required

• Mentor, coach, train engineers on validation principles and approaches.

• Support the development of a proactive and preventive quality systems culture throughout the business.

• Maintain current knowledge of global medical device regulations pertaining to quality systems and assist in facilitation of internal and third-party audits as needed throughout the TMC global network.

• Prepare, communicate, and evaluate team goals and objectives for continual improvement of the efficiency and effectiveness of the quality system.

• Performs other job-related duties as assigned.

Job Responsibilities (continued)

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

• Quality and business process knowledge

• Extensive experience with validations in a regulated industry.

• Knowledgeable of FDA, ISO 13485, EU MDR, MDSAP and global quality system requirements for medical devices.

• Strong analytical skills including trend and statistical analysis.

• Ability to use process development tools (ex. Lean Six Sigma)

• Leadership skills:

• Demonstrated ability to communicate and interact with all levels of the organization including Executive Leadership.

• Strong interpersonal skills to provide coaching, training, and direction.

• Demonstrated ability to provide clear direction and mentor personnel.

• Proven experience influencing across the organization to improve product or processes.

• Individual skills required:

• Strong proofreading and writing skills, as well as exemplary attention to detail.

• Demonstrated organizational and prioritization skills.

• Exceptional decision-making including the ability to rapidly understand complex changes and pace work completion to the needs of the company.

• Demonstrated initiative and ability to work independently while handling multiple tasks.

• Strong computer knowledge (MS Office), technical writing skills and proofreading ability

• Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required.

Qualifications/ Background Experiences

• B.S. degree or equivalent in Scientific or Engineering discipline required.

• Minimum 8 years overall experience with at least 4 years of related experience in medical devices/diagnostics, pharmaceutical or other regulated industry required with a focus on quality system responsibilities.

• Minimum of 5 years previous managerial experience preferred.

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.