Massachusetts Jobs

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 will be US REMOTE. As part of the Global Laboratory Office, you will closely work together with local PSG site Quality Laboratories to assure compliance, standardized processes at sites along with efficiency improvement, and running laboratories as a business.

Discover Impactful Work:

The Sr Manager of Quality will lead the deployment and maintenance lab productivity initiatives at NA PSG sites and tracking of related metrics as well as operationally supporting Quality Lab QMS standardization and developing plans and strategies to ensure compliance with regulations. Promote Lab efficiency increase also by defining and supporting strategies for introduction of new technologies that characterize Industry 4.0, from connectivity to advanced analytics, robotics and automation. An understanding of interaction of compliance, productivity and cost efficiency, will therefore be encouraged for this role, besides the ability to collaborate with PSG site and global representatives.

A Day in the Life:

• Understand future analytical capability needs and establish clear strategies and targets for labs automation and new technologies' introduction also defining the needed talent base a skills early on.

• Define and optimize Quality Laboratory processes and author SOPs by applying standard methodologies and following regulatory guidelines to standardize business processes with compliance focus.

• Author, build, and maintain GLO change management concepts and related material, e.g. playbooks, training material, work instructions, communication concept, etc.

• Lead deployment of global initiatives leading increasing of efficiency and standardization procedures at NA sites as well assuring sustainability.

• Define, track and assess Quality Lab metrics and identify related CAPAs.

• Train global and local colleagues on processes, SOPs, playbooks, etc.

• Work independently as part of a global virtual team and travel up to 25% of your time for deployment purposes and active site support.

How will you get there?

Education

• Bachelor’s degree in sciences required, preferably Chemistry or Biochemistry.

• Master’s degree is preferred.

• Operational excellence expertise, e.g. six sigma certification preferred.

Experience

• Minimum of 5 years laboratory experience in a GxP setting for pharmaceutical testing of drug products or small, large molecule drug substances and related raw materials.

Knowledge, Skills, Abilities

• Knowledge, experience and skills with Quality lab processes and corresponding procedures.

• Knowledge, experience, and skills on lean labs and operational excellence.

• Program management skills, goal-oriented approach and leading by influence, cross functional teams.

• Planning ability and flexibility based on tasks prioritization

• Expertise for qualification of analytical equipment.

• Shown knowledge of and experience with regulatory requirements applicable for biologics and pharmaceuticals to ensure adherence to guidelines.

• Ability to travel domestically and internationally up to 10 times per year.

• Excellent communication skills, written and verbal, second language preferred. Proficient in group and upwards presentations.

• Ability to work in a collaborative team environment. Ability to conduct training programs.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, 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.

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.