Site Quality Head (SR MANAGER)
Thermo Fisher Scientific · High Point, NC · 3 mo ago
On-siteEngineeringFull-time
Work Schedule
Standard (Mon-Fri)
About the Role
You’ll 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.
Responsibilities
- Guide strategic quality initiatives and support a culture of continuous improvement across the organization.
- Oversee quality management systems, ensure regulatory compliance, and enhance customer experience through excellent quality standards.
- Work closely with cross-functional teams to develop and implement quality strategies that support our mission.
- Manage quality assurance and quality control teams.
- Build strong partnerships with operations, R&D, commercial teams, and customers.
- Guide process improvements through Practical Process Improvement (PPI) methodologies and risk-based approaches.
- Support quality initiatives that deliver consistent product excellence while meeting business objectives.
- Develop quality professionals, lead investigations, and implement data-driven solutions that enhance our quality systems and customer satisfaction.
Requirements
- Education: BS degree required. Preferred fields of study: Science, Engineering, Chemistry, or related technical field. Advance degree highly preferred.
- Experience: Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in pharmaceutical, medical device, or regulated life sciences industry. 5 years of quality management/leadership experience. Experience implementing continuous improvement initiatives. Experience with quality tools including FMEA, Risk Analysis, and Root Cause Analysis. Experience hosting regulatory inspections and customer audits.
Qualifications
- Knowledge, Skills, Abilities: Expert knowledge of global quality standards (ISO 13485, ISO 9001, FDA 21 CFR 820, EU MDR/IVDR). Strong understanding of quality management systems and GMP requirements. Demonstrated experience leading quality investigations, CAPA, and change control processes. Excellent project management and cross-functional leadership abilities. Strong data analysis and problem-solving capabilities. Excellent written and verbal communication skills. Ability to build collaborative relationships at all levels. Proficiency with quality management software systems. Ability to travel up to 25%.
Benefits
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits!
Pay
Competitive remuneration
Schedule
Standard (Mon-Fri)