Senior Quality Manager, remote at Thermo Fisher Scientific

Indiana, United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

B.S. or equivalent experience in a Scientific or related field
10+ years of experience in Quality Assurance, preferably in the Pharmaceutical industry
5+ years of people management experience
ASQ preferred
QMS experience preferred
Extensive knowledge of related regulatory requirements
Outstanding collaboration and communication skills
Ability to mentor and influence others effectively
Established track record in guiding and controlling quality systems functions to meet regulatory requirements
Demonstrated ability to provide compliant and practical solutions to complex product quality issues
Strong focus on continuous improvement and client-centric approach

Responsibilities

Provide Quality oversight to all aspects of the Quality System to ensure site compliance with corporate directives, site procedures, and regulatory expectations
Coordinate change control programs, SOP management, document management, and system administration
Lead the site Data Integrity program and Computer System Validation
Lead digital quality projects in accordance with the site's quality strategy
Coordinate training and Personal Quality Initiative programs
Develop and implement risk management programs, including communicating risk registers and mitigation strategies to the site Quality Head and SLT
Participate in regulatory inspections, Corporate audits, and client audits; develop risk mitigation strategies based on findings
Engage with clients to address their questions and concerns regarding site strategy for controlling product quality through quality systems
Champion quality initiatives to continuously elevate the quality culture
Mentor and coach individuals within the quality department to maintain a focus on quality and compliance

Skills

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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