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?

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 biotechnology industry, either in a customer-facing role or as an end-user of bioprocessing technologies; must   demonstrate   strong understanding of customer quality, regulatory, and operational expectations, and familiarity