Quality Manager

Work Schedule

Environmental Conditions

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.

Responsibilities

• Investigate and resolve product quality issues, including deviations, out-of-specification (OOS) results, and customer complaints.
• Develop and implement CAPAs to prevent recurrence of quality issues.
• Collaborate with manufacturing & supply chain teams to ensure product quality throughout the product lifecycle.
• Review and approve batch records, validation protocols, and other quality-related documentation.
• Support regulatory submissions and respond to regulatory inquiries related to product quality.
• Conduct risk assessments and ensure compliance with regulatory and company standards.
• Train and mentor Commercial team on quality systems and best practices.

Requirements

• Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Biochemistry, Chemical Engineering, or a related field.
• more than 5+ years of experience in quality assurance, quality control, or manufacturing within the bioproduction industry.
• Certifications such as Six Sigma (Green Belt/Black Belt), Lean Manufacturing, or Quality Auditor (CQA) are advantageous.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!