Senior Quality Manager
RemotePosted 1 month ago Expired
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Upload Your ResumeAbout This Role
This role involves leading and maintaining a robust Quality System at Thermo Fisher Scientific, ensuring compliance with regulatory guidelines and driving continuous improvement initiatives. The Senior Quality Manager will oversee quality aspects, coordinate programs, and mentor quality department members.
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
Requirements
- 10+ years of experience in Quality Assurance
- 5+ years of people management experience
- 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
Qualifications
- B.S. or equivalent experience in a Scientific or a related field
- 10+ years of experience in Quality Assurance (preferably Pharmaceutical industry) and 5+ years of people management experience
Nice to Have
- Experience in the Pharmaceutical industry
- QMS experience
Benefits
Certifications
About Thermo Fisher Scientific
Thermo Fisher Scientific is a company that enables customers to make the world healthier, cleaner and safer, providing solutions for some of the world's toughest challenges, across various industries including pharmaceutical, biotechnology, clinical labs, academia, government, environmental, and foo...