Thermo Fisher Scientific Manager, IT Quality Management Systems Support in Carlsbad, California

Job Description

Manager, IT Quality Management Systems Support

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

The Manager, IT Quality Management Systems Support (IT-QMSS) has primary accountability for the support of the applications that comprise Thermo Fisher’s Quality System to ensure that these systems and associated support services meet the needs of the company’s global business. This role will also provide support and maintenance for the Company’s EHS systems (WERCS, SHED). The Manager IT-QMSS must be results-driven and team-oriented with an enthusiastic attitude, strong leadership, broad perspective, deep expertise in quality systems, excellent interpersonal skills, and the ability to influence outcomes in a changing regulatory environment. The Manager, IT-QMSS maximizes the effectiveness of the service offering through direct management of IT-QMSS resources, and effective collaboration and influence with company leadership, functional area leaders, and key subject matter experts throughout the organization. The candidate must be knowledgeable in cGMP (current Good Manufacturing Practice) as it pertains to medical devices, drugs, and biologics. The candidate must have management experience, and a successful track record in supporting information technology systems in a highly dynamic environment.

Responsibilities:

  • Provide application support for Thermo Fisher’s enterprise-wide Quality Management Systems and the systems required to support Regulatory Affairs and Employee Health & Safety, inclusive of setting the performance targets and tactics to deliver robust support services

  • Lead Thermo Fisher’s Quality Management Systems Support function for IT, with direct management responsibility for the staff and accountability for ensuring that this team has the technical and professional skills, organizational structure, capacity, and business processes in place to maximize the value of Thermo Fisher’s Quality Management Systems

  • Facilitate effective cross-functional communication, alignment, collaboration, leadership and execution on quality-related objectives, plans, and priorities

  • Provide input for changes in systems, processes, staffing, and organizational development for assigned areas of responsibility, providing clarity on costs, benefits, alternatives, resource requirements, and other relevant information to enable timely, effective decision making

  • Identify and suggest functional improvements to the Document Control and Quality Assurance systems

  • Ensure that budgets, schedules, and department performance requirements are met

  • Keeps abreast of the evolving regulatory policy and industry best practices related to Quality systems

  • Other duties as assigned

Qualifications:

  • Bachelor degree in Computer Science, or engineering or related field

  • Minimum 2 years of experience in IT and/or QMS leadership and management roles with direct management responsibility for personnel and responsibility for a broad spectrum of Quality Management System elements

  • Demonstrated success leading cross-functional implementation and maintenance of Quality Management Systems

  • Well versed with regulatory compliance (GxP, 21CFR Part 11, EU Annex 11 etc.)

  • Experience in participating in regulatory inspections, presenting/defending IT functions in audits or regulatory inspections is a plus

  • Exceptionally strong team leader and team player with excellent interpersonal and communication skills, and experience working with end-users in a coaching capacity

  • Detail-oriented with strong organizational skills and high quality standards

  • Outstanding written communication skills with experience in authoring both internal and externally facing quality related documents

  • Good interpersonal and verbal communication skills, with the ability to effectively communicate with employees, functional area and executive management, customers, and business partners

  • Self-motivated, hands-on critical thinker and problem solver, with the ability to lead by example, an enthusiastic, optimistic outlook, and a collaborative style

  • Ability to integrate and apply feedback in a professional manner

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.