Massachusetts Green Jobs

Job Description

When you join Thermo Fisher Scientific, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science and with the largest investment in R&D in the industry, you will be empowered to realize your full potential as part of a fast-growing, global organization that values your passion and unique contributions. Our commitment to you and our 80,000 colleagues is to provide the resources and opportunities you need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information

At the Plainville site within the Viral Vector Services (VVS), a division of Thermo Fisher Scientific, we deliver Advanced Therapeutics from process development through commercial supply, and we offer the expertise and resources vital to help clients deliver innovative gene therapies

How will you make an impact?

You will provide the cross functional leadership, Quality expertise in cGMP US regulation, EU and rest of world guidance, which enables Plainville to reliably meet and/or exceed product supply targets while achieving high levels of quality.

As a leader within the Quality team and the site, you will coordinate QA Operations including Batch Record Review, Deviation containment, and QA on the floor. With your excellent interpersonal skills you will ensure that Plainville has highly satisfied internal and external customers, and successful regulatory inspections.

What will you do?

• Responsible for leading a team of QA specialists to ensure Quality product within the facility

• Implement robust business processes to support the Right First Time execution.

• Implement and maintain a Culture of Quality and drive Quality Maturity

• Builds and maintains expertise in the QA Ops teams, including development of staff. Applies biologics manufacturing experience to ensure that operations meet customer and regulatory expectations and requirements for manufacturing at all phases of product development.

• Drive continuous improvement and Operational Excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.

How will you get here?

Education

• BS in Biological Science or related technical field

Experience

• At least 8-10 years of related experience in the Quality Unit

• Proven understanding of Quality procedures, processes and guidelines. Recognized by colleagues as a source of expertise.

• Experience in Raw Material and Batch Disposition

• Experience leading conversations with customers.

Knowledge, Skills, Abilities

• Extensive exposure to cGMP environment.

• Understanding of applicable regulatory requirements.

• Demonstrate excellent organization and time leadership skills.

At Thermo Fisher Scientific, each one of our 80,000 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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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.