Sr Manager, Quality Program Lead

---

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.

How will you make an impact?

The Quality Assurance Sr. Manager is responsible for leading a group of Quality SMEs (QPLs, Quality Program Leads) who ensure Quality in multidisciplinary customer project teams, and as a liaison among customers and other departments. Leads, as applicable, meetings focused on quality items, product-related projects, and customer related topics. This position requires a highly motivated, tenacious, self-starter who can assimilate new information quickly and enjoys working closely with others within a fast-paced project execution environment. The individual will perform activities in support of dispositioning clinical and commercial drug product while ensuring compliance with VVS directives and procedures, customer requirements, and regulatory standards.

What will you do?

• Manages a team of quality specialists who are responsible to ensure the quality of Client projects and any Quality deliverable for the project team.
• Provides specific technical knowledge for the Quality Unit organization, including participating in investigations, studies and trending evaluation as well as innovation and improvement projects.
• Delegates and Collaborates to ensure that tasks are prioritized, completed on time to the required standard (internal and customer's), and communicated in an effective and timely manner internally and externally.
• Performs and leads a team in crafting, reviewing and approving (as applicable) documentation related to customer's projects such as; assay methods, validations, tech transfer, production records, release specifications, sampling plans and stability protocols and reports
• Creates, maintains and ensures compliance with Quality Agreements.
• Perform monitoring of the process and maintenance of program metrics from a quality perspective
• Ensures regulatory and customer inspection readiness and represent the department and participate in audits as required

How will you get here?

Education:

• Bachelor's Degree in Sciences preferred - HS Diploma/ GED and equivalent relevant work experience is a minimum requirement

Experience:

• 8+ Years of cGMP industry experience
• 4+ years proven leadership experience
• Extensive Exposure to cGMP environment and Quality systems

Knowledge, Skills, Abilities:

• Expert understanding of US and EU cGMP guidelines and requirements recognized by colleagues as a source of expertise.
• Excellent interpersonal and communications skills; written and oral, in a diverse community
• Ability to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to area management.
• Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environment
• Ability to understand operational documents for GMP compliance, accuracy and completeness.
• Able to prioritize and resolve conflict within project teams

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 global team of 90,000 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!

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-*. 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.