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Sr. QA Manager, Quality Program Lead

Company: Thermo Fisher Scientific Inc.
Location: Alachua
Posted on: June 13, 2021

Job Description:

Job Description

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

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 the 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 customers 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 or HS Diploma/ GED and equivalent relevant work experience required

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

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.

Keywords: Thermo Fisher Scientific Inc., Gainesville , Sr. QA Manager, Quality Program Lead, Other , Alachua, Florida

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