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Senior Quality Manager
Thermo Fisher ScientificSenior Manager of Quality at Thermo Fisher Scientific driving excellence and compliance in Oral Solid Dose business. Leading quality initiatives and support across global sites in pharmaceutical industry.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quality management and compliance within the pharmaceutical and life sciences sectors, with a strong focus on continuous improvement, regulatory standards, and effective leadership. Proven ability to implement quality strategies, manage cross-functional teams, and drive operational excellence.
Highest-signal resume keywords
Quality Management LeadershipContinuous Improvement InitiativesRegulatory Compliance ExpertiseData Analysis and Problem-SolvingQuality Management Systems Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Quality ManagementContinuous ImprovementFMEARisk AnalysisRoot Cause AnalysisCAPAChange ControlProject ManagementQuality Standards KnowledgeGMP Requirements
Soft Skills
Excellent CommunicationCollaborative Relationship BuildingCross-Functional Leadership
Tools & Technologies
Quality Management Software Systems
Certifications & Qualifications
ASQLean Six Sigma
Industry Keywords
PharmaceuticalMedical DeviceRegulated Life SciencesISO 13485ISO 9001FDA 21 CFR 820EU MDRIVDR
About the role
Key responsibilities & impact- You will play a key leadership role in advancing quality, compliance, and operational excellence across the Oral Solid Dose business unit.
- This role is responsible for driving continuous improvement across global sites, leading compliance initiatives, and identifying opportunities to improve efficiency, consistency, and quality system performance.
- You will serve as a critical liaison between global quality functions and site quality leadership, helping to align business unit priorities with site execution.
- Working closely with Site Quality Heads, operations, technical teams, regulatory, commercial, and client-facing functions, you will support the implementation of global quality strategies, strengthen inspection readiness, and promote a culture of proactive, risk-based quality management.
- You will also support clients and quality heads for escalations, helping to ensure timely communication, effective issue resolution, and strong customer confidence.
- You will support complex investigations, CAPA effectiveness, quality performance reviews, and cross-site improvement initiatives while leveraging Practical Process Improvement (PPI), data-driven decision-making, and standardized best practices.
- You will help drive compliance maturity, share learnings across sites, and enable consistent execution of quality expectations across the global Oral Solid Dose network.
Requirements
What you’ll need- BS degree required
- Preferred Fields of Study: Science, Engineering, Chemistry, or related technical field
- Advanced degree preferred
- Professional certifications desired (ASQ, Lean Six Sigma, etc.)
- Advanced Degree plus 4 years of experience, or Bachelor's Degree plus 6-8 years of experience in pharmaceutical, medical device, or regulated life sciences industry required
- 5 years of quality management/leadership experience required
- Experience implementing continuous improvement initiatives
- Experience with quality tools including FMEA, Risk Analysis, and Root Cause Analysis
- Experience hosting regulatory inspections and customer audits
- 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 50%.
Benefits
Comp & perks- We offer competitive remuneration
- annual incentive plan bonus scheme
- healthcare
- a range of employee benefits!