Director, Quality Purification and Pharma Analytics

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, 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. As Director of Quality at Thermo Fisher Scientific, you'll lead strategic quality initiatives that directly impact healthcare and scientific advancement. This role will be responsible for building a customer-focused quality culture and associated quality processes . This includes a dedication to optimizing the customer experience through customer feedback and delivering products that represent industry-leading standards of product quality. Location This role is part of the Bioproduction Group within the Purification and Pharma Analytics business unit and is located at the Bedford, Massachusetts PPA site. What will you do? ​ Define the Quality strategy for the PPA products in alignment with Group and Corporate goals. Ensures adequate deployment and execution of such strategy Drive with inten sity a robust quality culture across the organization Provide Quality leadership for the PPA multi-site network . Manage matrix relationships within Thermo F isher to ensure all product value stream touch points are aligned to deliver Quality products and processes Drive resolution to quality issues as needed and communicates internally to senior leaders and to diverse audiences in an effective manner. Solves problems in complicated situations using analytical skills, creativity, judgment, and technical expertise . Partners with other SMEs as needed Apply Quality Risk Management to prevent risk of failure modes that impact supply of consistent supply of Quality PPA products Conduct advanced data analyses to determine quality problems and to identify larger scale quality improvements . An adequate sense of urgency is expected Participate in cross functional team projects (R&D, Mfg , Vendors, etc ). How will you get here? Education Bachelor’s degree or above in Science , e ngineering d isciplines or similar fields Experience 10 + years or more experience within the Pharmaceutical or Medical Device Industry - supporting Regulated Products At least 5 years of experience managing /leading a multi-site organization Audit (ISO13485 or similar) or inspection (FDA or similar) management experience Customer facing experience Knowledge, Skills, Abilities ​ Change agent with experience of driving a robust quality culture Business expertise , understand how quality impacts a business Expert knowledge of Quality Management System design and oversight from a p harmaceutical perspective and/or medical d evice field Strong communication skills, written and verbal. Experience managing very complex quality issues including escalations within the Company and with Customers. This includes direct verbal interaction , documented communications (email, letters, PowerPoint), and issuing written reports Knowledge of Compliance with quality standards (e.g., 21 CFR Part 820, ISO 13485, 9001) Experience with the use of key q uality tools e.g. FMEA, Risk Analysis, RCA and g lobal s ystems e.g. TrackWise , AGILE, E1/SAP, LIMS or similar Training/understanding in Lean Sigma/Six Sigma processes Preferred Knowledge, Skills, Abilities ​ Experience within the pharmaceutical and/or biotechnol