Sr Quality Manager, Customer Advocacy SUD

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

This position is an important function of the Single Use Division within the BioProduction Group to develop the customer experience and business growth. This role could be performed either remote or located at any of our US SUD sites.

Discover Impactful Work:

The role is part of the Quality Customer Advocacy program which is seeking to develop strong connections with Core Account customers, develop relationships, resolve quality situations and act proactively.

This role will make an impact by developing quality connections with the strategic Core Account customers and serve as the liaison on Quality related topics and issues.

A day in the Life:

Develop strong relationships with key quality contacts at Core Accounts. Acts as a main point of contact for these customers in regard Quality issues and general Quality-related initiatives and programs. Provide prompt response times.

Conducts track and trend and presents customer related quality data as part business and quality reviews with customers.

Identifies customer concerns and communicate customer experiences with applicable internal functions to mitigate potential complaints or customer concerns.

Promote positive customer success.

Drive internal actions required to ensure adequate and timely resolution of Customer Quality issues.

Prepare information for internal quality reviews such as Quality Management System (QMS) reviews and internal customer reviews.

Be prepared to speak on behalf of the Quality Organization. Drive awareness of key trends or areas of opportunity to work proactively.

Works closely with the Senior Quality Customer Advocacy Manager BPG and Site Quality Heads and other functions to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure timely follow ups.

Leads customer calls regarding Quality opportunities, including documenting meeting notes and actions, identifying action owners, facilitating internal discussions, follow ups and timely feedback to the customer.

Working with relevant key partners with the implementation of Quality Agreements for key customers.

Keys to Success:

Education

Bachelor’s Degree in Science or related field required

Three to five years in a Quality leadership role.

Experience with investigation writing, root-cause analysis, and report writing is a must

ASQ or similar quality certification (preferred)

Experience

Meaningful experience in Quality pharmaceutical or Medical Device manufacturing;

Experience of Single Use Technology products and manufacturing processes

Prior experience working with product complaint investigation, CAPA, and non-conformance records including root-cause analysis

Experience leading very sophisticated quality issues including product quality or service-related concerns raised within the Company and with Customers

Experience interacting with customers including direct verbal interaction and issuing written reports

Knowledge, Skills, Abilities

Strong interpersonal and communication skills

Ability to demonstrate business insight and drive growth.

Ability to summarize sophisticated quality problems and deliver executive updates

Knowledge of pharmaceutical, biologics and/or medical device quality systems (FDA, ISO13485, MDSAP, etc.)

Project management skills including ability to supervise and follow-up on actions across multiple functions, sites, and locations.

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Physical Requirements / Work Environment

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000 colleagues, we share a common set of values – Integrity, Intensity, Innovation and Involvement – working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.