Sr Manager, Quality at Thermo Fisher Scientific in Austin, Texas

Job Description:

Job Description



Genetic Science Division (GSD) is looking for a strong quality leader to lead the Austin Site Quality organization to achieve Quality objectives and assure compliance with industry standards.


The Sr Manager, Quality is a leadership position responsible for implementing and improving Site Quality Management System and Quality Assurance structure to cover various internal functions, build scale, and most importantly, better serve our customers.


This position reports directly to the Sr Director of Quality, GSD.



Key Duties and Responsibilities



Support and provide expertise to the Quality Management System (QMS) and Quality department to successfully meet or exceed goals and targets


Collaborate with the various functions to ensure the quality management system is comprehensive, incorporates standard processes, and is consistent with the strategic plan


Product Development responsibilities including design controls, risk management, document control and record management, and supplier management


Manufacturing responsibilities including master record, training, process controls, labeling, change control, and CAPA


Responsible for monitoring and measurement including validations, calibrations, customer feedback and complaints, internal audits


Responsible for all site quality metrics and reporting for monthly and quarterly business reviews - e.g., Product Complaint rates, Cost of Poor Quality, CAPA, etc.


Support and provide quality expertise to the business process transfer activities - e.g., process implementation/validation


Hire and retain a diverse, highly qualified staff and provides ongoing performance feedback. Set goals which align to department plans and lead the execution of goals through coaching and mentoring


Ensure continuous improvement through the Practical Process Improvement (PPI)


Install and maintain a quality culture - Right First Time



Minimum Requirements/Qualifications:



Bachelor of Science Degree in - Life Sciences, Engineering or related science/engineering degree preferred


10+ years of professional quality experience - quality leadership experience preferred


Understanding of the Life Sciences and IVD/Medical Devices industries and required compliance regulations for Genetic Sciences products and processes


Solid understanding and experience with ISO 9001 and ISO 13485 standards


Experience in MDSAP, IVD/IVDR, 510K and GxP requirements preferred


Ability to travel domestically and internationally - up to 15%


Expert knowledge and experience implementing the following:

• Design and Process FMEA's (Failure Mode Effects Analysis)


• CAPA (Corrective and Preventive Actions) process


• NPI (New Product Introduction) process - Design Transfer, V&V


• Complaints Handling process


• Change Control process

Desired Qualifications:



Contributes as a valued team member and colleague with leaders at all levels


Experience working and providing customer support, investigations, and relationship management


Validated communication and customer management skills


Experience supporting change management efforts


Validated people leadership skills


Demonstrates personal awareness and desire for continual learning and personal development


Hands-on and action oriented - Normally receives little instruction on day-to-day work, general instructions on new assignments


Must possess the presentation skills and integrity to project a professional image, both internally and externally


Strong interpersonal, verbal and written communications skills are crucial Apply Now