**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **What You Will Do:** + Define and own the quality strategy for Single-Use Technologies, ensuring alignment with corporate and group-level objectives. + Champion a robust quality culture across all levels of the organization. + Drive a customer-centric culture by positioning quality as a competitive differentiator that improves customer trust, happiness, and dedication. + Provide quality leadership across a multi-site manufacturing network. + Serve as a key customer-facing representative, building and maintaining strong professional relationships with customer Quality counterparts. + Navigate matrixed relationships across Thermo Fisher to ensure quality is embedded throughout the entire product lifecycle. + Mentor and develop talent within the Quality organization; provide training and mentoring as needed. + Lead resolution efforts for complex quality issues, ensuring clear communication to senior leadership and other collaborators. + Apply Quality Risk Management principles to mitigate potential failure modes and ensure uninterrupted supply of high-quality products. + Conduct advanced data analysis to identify root causes, trends, and large-scale quality improvement opportunities. + Collaborate cross-functionally on product introductions and continuous improvement projects, integrating risk management and compliance throughout the product lifecycle. **Professional Experience:** + Minimum of 10 years in the pharmaceutical or medical device industry, with a focus on regulated products. + At least 5 years of leadership experience leading multi-site operations. + Strong experience leading audits (e.g., ISO 13485). + Direct experience engaging with customers on complex quality matters. **Skills & Proficiencies:** + Proven change agent with a track record of incorporating a strong quality approach. + Strategic business insight and a deep understanding of how quality enhances business success. + Expertise in Quality Management Systems within a pharmaceutical or medical device context. + Outstanding interpersonal skills, both verbal and written, with experience handling high-stakes quality blocking issues. + Proficient in industry standards and regulations including 21 CFR Part 820, ISO 13485, and ISO 9001. + Strong command of quality tools such as FMEA, Root Cause Analysis, Risk Assessments, and quality systems like TrackWise, MasterControl, AGILE, SAP, or LIMS. + Training or certification in Lean/Six Sigma methodologies. **What You Will Need:** + Bachelor’s degree or higher in a scientific or engineering field. + Familiarity with Single-Use Technologies bioprocessing, or new product introductions in pharma or med device. + Experience in supplier quality oversight and procurement support. + Project management experience in a regulated environment. + Knowledge of Lean Production Systems. + Regulatory Affairs or Quality certifications (RAPS, ASQ, etc.) are a plus. **Apply today! http://jobs.thermofisher.com** Accessibility/Disability Access Thermo Fisher Scientific provides accessibility services for job seekers needing accommodations during the application process. This includes help for hearing, vision, mobility, or cognitive impairments. + This phone line is for disabled job seekers needing application assistance. Messages for other issues won't be answered. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.