QMS Manager at Thermo Fisher Scientific

St Louis, Missouri, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Life Sciences, PharmaceuticalsIndustries

Requirements

Bachelor’s Degree or equivalent experience in Life Sciences, Biotechnology, Engineering, or a related field
More than 8 years of experience in a GMP Environment
A minimum of 5 years' experience in Quality Assurance or Quality Compliance (preferred)
3+ years in a leadership role (preferred)
In-depth knowledge of FDA, EMA, and other applicable regulatory requirements
Proficient with computer (MS Office) and internet skills; proficient in the use and understanding of controlled documentation and data systems
Well organized and able to work independently with minimal supervision
Skilled in risk management application
Demonstrated dedication to fundamental principles of Integrity, Respect, and Excellence
Knowledge of pre-license/pre-approval inspection readiness and regulatory submissions (preferred)
Experience with regulatory inspections (preferred)
Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member
Proven ability to influence others and lead significant change
Strong communication and presentation skills, both written and verbal
Ability to drive functional, technical, and operational excellence
Ability to encourage and foster innovation, collaboration, transparency, and team efficiency

Responsibilities

Lead all aspects of the Quality Management Systems team and ensure site compliance with FDA, EMA, and other cGMP regulations
Coordinate programs such as Change Management, CAPA management, local systems administration, and Metrics
Provide leadership by developing and empowering staff, encouraging relationships, putting staff in positions to succeed, supporting personal career goals while achieving organizational goals, building effective teams, promoting engagement, and creating a motivating climate
Coordinate, manage, and ensure the successful day-to-day operations of the QMS team for the company
Manage the change management program, including planning, execution, oversight, and governance
Review and approve department standard operating procedures
Coordinate daily activities to ensure appropriate quality and maintenance of schedules
Provide support for site safety initiatives
Perform any other tasks as requested by Senior Management to support Quality oversight activities
Represent the company at regulatory inspections, respond to questions, and support responses and corrective actions as appropriate
Set objectives and tasks for staff and regularly review their progress
Effectively communicate with peers, Manufacturing, Process Development, Procurement, and Quality Control staff to resolve technical issues and direct activities

Skills

QMS

cGMP

FDA

EMA

Change Management

CAPA

GMP

SOP

Regulatory Inspections

Quality Oversight

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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