Site Quality Manager at Thermo Fisher Scientific

Charlotte, North Carolina, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Manufacturing, Life Sciences, Filtration, Medical DevicesIndustries

Requirements

Bachelor’s degree or equivalent experience in a scientific or technical field
5+ years in Quality Assurance experience in the pharmaceutical, bioprocessing, food and beverage industries, or other regulated industry
Prior direct and matrix people leader experience
Strong working knowledge of Good Manufacturing Practices (GMP), ISO9001, Good Documentation Practices (GDP), and CAPA systems
Strategic problem solver with a practical approach to complex quality challenges
Excellent communication and presentation skills, including use of Microsoft Office tools
Strong organizational and prioritization capabilities
Proficiency in risk management tools such as FMEA, Root Cause Analysis (RCA), and statistical process control (SPC)
Ability to work in a standard office environment including occasional visits to manufacturing areas that require cleanroom gowning

Responsibilities

Develop, implement, and maintain the site's Quality Management System (QMS) aligned with applicable regulatory standards (e.g., ISO9001, GMP, ISO13485)
Lead a culture of continuous improvement, promoting proactive identification and resolution of quality risks
Participate on the site leadership team in planning for the site, incorporating quality initiatives into broader operational goals
Maintain compliance with all applicable regulatory and customer requirements and internal quality standards
Responsible for internal and external audits, including ISO, customer, and other external certifying bodies including implementation of Corrective and Preventive Actions (CAPA) for findings and deviations
Lead and mentor the Quality team to provide the best possible service through effective communication, scientific leadership, and problem solving
Navigate a sophisticated functional and technical matrix, collaborate across functions, troubleshoot problems, interpret data and resolve next steps based on risk-based approach
Track and report key performance indicators to assess quality system efficiency
Ensure equipment qualifications, process validations, and calibration activities are properly completed and documented

Skills

Key technologies and capabilities for this role

Quality Management SystemQMSISO9001GMPISO13485CAPAContinuous ImprovementAuditsRegulatory ComplianceLeadership

Questions & Answers

Common questions about this position

What qualifications are required for the Site Quality Manager role?

A Bachelor’s degree or equivalent experience in a scientific or technical field is required, along with 5+ years in Quality Assurance experience in regulated industries like pharmaceutical, bioprocessing, food and beverage, or similar. Prior direct and matrix people leader experience is also necessary.

What key skills are needed for this position?

Candidates need strong working knowledge of GMP, ISO9001, GDP, and CAPA systems, along with strategic problem-solving abilities, excellent communication and presentation skills including Microsoft Office, and the ability to lead and mentor teams.

Where is this job located and what is the work arrangement?

The role is based in Charlotte, NC, with a standard Monday-Friday work schedule. Some degree of PPE is required in office and environmental conditions adhering to GMP safety standards.

What does the company culture emphasize at Thermo Fisher Scientific?

The company promotes a culture of continuous improvement, proactive quality risk resolution, and collaboration across functions, while enabling teams to achieve career goals and address global challenges like environmental protection and healthcare.

What makes a strong candidate for the Site Quality Manager position?

Strong candidates will have 5+ years of QA experience in regulated industries, leadership experience, and expertise in GMP, ISO standards, CAPA, along with excellent communication and problem-solving skills to lead teams and manage audits.

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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