Job Title: Sr Mgr, Quality Systems
Requisition ID: 106257BR

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

The Quality Systems Senior Manager will play a key role in the Bioproduction Divisions Automation and Equipment Business’s Initiative to achieve and maintain ISO 13485:2016 conformance, and cGMP compliance. This is an exciting high growth, fast paced business providing equipment and services to pharmaceutical manufacturing.

How will you make an impact?

The Senior Manager, quality will make an impact through improvement to processes and SOPs, documentation, record keeping and Quality Fundamentals. This individual will be working in a position of leadership and influence to direct quality system and fundamentals activities in adherence to the quality policy. Key elements of the program include a top down re-engineering of the QMS, leading management reviews and managing programs within the quality system such as, but not limited to, calibration program, CAPA coordination, training, on-boarding programs, adhering to emerging standards, and back up to the management representative.

What will you do?

• Responsible for Leading and maintaining the quality fundamentals of the QMS such as, but not limited to CAPA, Internal Audit program, Calibration program, risk register, establish SOPs according to applicable Standards and Regulation.
• Lead development of continuous improvement, including metrics development and periodic reporting.
• Assist in the review and disposition of deviations/non-conformance and complaints.
• Prepares and assists with the Management Review
• Manage and develop a growing team of Quality professionals as well as coach/mentor others to become leaders with focus on customer experience of product quality
• Develop and lead quality programs on-boarding training for new employees

How will you get here?

• Bachelor's Degree or higher in the Scientific or Technical field (i.e. Chemistry, Biology, or Engineering) preferred.
• A minimum of 5 years of related work experience with a hardware device adhering to ISO 13485 and/or cGMP
• Medical Device, Biotechnology or Pharmaceuticals experience a plus.
• Proven Leadership skills
• Experience in management of a direct team
• Proven Collaboration, Influence to meet cross functional goals and objectives.
• Proven effective communication skills are required, both written and verbal.
• Direct experience in Internal Audits, CAPA, Calibration, and Risk management.
• Data Analysis
• Desired: Ability to leverage tools such as Excel Pivot Table, Visio and SharePoint a plus
• Proven attention to detail and appropriate, diligent follow up.
• Excellent interpersonal skills, problem solving skills, planning/organization skills, strategy and customer focus.
• Ability to handle multiple tasks while ensuring timely and accurate completion.
• Proficient with personal computer skills, specifically Microsoft office applications, with the ability to learn new computer systems quickly
• LEAN Sigma or experience with Toyota Production System based quality system a plus

At Thermo Fisher Scientific, each one of our 70,000 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.

Apply today! http://jobs.thermofisher.com

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.