Sr. QA Manager, Quality Program Lead
Company: Thermo Fisher Scientific Inc.
Posted on: June 13, 2021
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
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
- 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
- Creates, maintains and ensures compliance with Quality
- 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?
- Bachelor's Degree in Sciences or HS Diploma/ GED and equivalent
relevant work experience required
- 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
- 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
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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