Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Job Description:

As part of the Thermo Fisher Scientific team discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Are you ready to take on a pivotal role where you can make a significant impact on the world? Thermo Fisher Scientific Inc. is seeking an ambitious Site Quality Manager to join the team in Charlotte, NC supporting Filtration and Separation products sold globally.

Key Responsibilities:

• Develop, implement, and maintain the site's Quality Management System (QMS) aligned with applicable regulatory standards (e.g., ISO9001, GMP, ISO12485)

• 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.

Qualifications:

• Bachelor’s degree or equivalent experience in a scientific or technical field required.

• 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.

Knowledge, Skills, Abilities:

• Strong working knowledge of Good Manufacturing Practices (GMP), ISO9001, 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).

Physical Requirements / Work Environment:

• Ability to work in a standard office environment including occasional visits to manufacturing ares that require cleanroom gowning.

Join us and contribute to our mission of making the world healthier, cleaner, and safer! We offer a collaborative environment where your outstanding skills will be valued and your career aspirations supported.