Senior Quality Leader - Compliance & Process Improvement

Regulatory Jobs; Oakwood (OH); On-site; USD 140,000 - 190,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Senior Manager of Quality to drive strategic quality initiatives and support a culture of continuous improvement. You will oversee quality management systems, ensure regulatory compliance, and enhance customer experience through stringent quality standards.

You will manage QA/QC teams, build partnerships with operations, R&D, and commercial groups, and lead investigations using PPI and risk-based approaches to maintain inspection readiness and

Qualifications

• Advanced degree plus 6+ years in pharma, medical device, or regulated life sciences.
• 5+ years of quality leadership experience.
• Expert knowledge of ISO 9001:2015 and ISO 17025.
• Experience hosting regulatory inspections and customer audits.

Responsibilities

• Lead strategic quality initiatives and continuous improvement.
• Oversee QMS, regulatory compliance, CAPA and change control processes.
• Develop site leadership and partnerships with operations, R&D, and customers.

Skills

Quality leadership

Cross-functional leadership

ISO quality standards

CAPA investigations

Risk analysis

Education

Advanced degree

Bachelor's degree

Tools

QMS software

FMEA

Root cause analysis

Job description

Thermo Fisher Scientific is seeking a Senior Manager of Quality to drive strategic quality initiatives and support a culture of continuous improvement. You will oversee quality management systems, ensure regulatory compliance, and enhance customer experience through stringent quality standards.

You will manage QA/QC teams, build partnerships with operations, R&D, and commercial groups, and lead investigations using PPI and risk-based approaches to maintain inspection readiness and