Director, Quality Purification and Pharma Analytics

Location

This role is part of the Bioproduction Group within the Purification and Pharma Analytics business unit and islocatedatthe Bedford MassachusettsPPAsite.

What will you do

• Define the Quality strategy for thePPAproducts in alignment with Group and Corporate goals. Ensures adequate deployment and execution of such strategy

• Drive with intensitya robust quality culture across theorganization

• Provide Quality leadership for thePPAmulti-sitenetwork.

• Manage matrix relationships within ThermoFisher to ensure all product value stream touch points are aligned todeliverQuality productsand processes

• Drive resolution to quality issues as needed and communicates internally to senior leaders and to diverse audiences in an effective manner.Solvesproblems in complicated situations using analytical skills creativity judgment and technicalexpertise. Partners with other SMEs as needed

• Apply Quality Risk Managementto prevent risk of failure modes thatimpactsupply of consistent supply of QualityPPAproducts

• Conduct advanced data analyses todeterminequality problems and toidentifylarger scale quality improvements. An adequate sense of urgency is expected

• Participate in cross functional team projects (R&DMfg Vendorsetc).

How will you get here

Education

• Bachelors degree or above inScienceengineeringdisciplinesor similar fields

Experience

• 10years or more experience within thePharmaceutical or Medical DeviceIndustry - supporting Regulated Products

• At least 5 years of experience managing/leadingamulti-siteorganization

• Audit (ISO13485 or similar) or inspection (FDA or similar) management experience

• Customer facing experience

Knowledge Skills Abilities

• Change agent with experience of drivinga robust quality culture

• Businessexpertiseunderstandhow qualityimpactsa business

• Expert knowledge of Quality Management System design and oversight from apharmaceutical perspective and/or medicaldevice field

• Strong communicationskills written and verbal. Experience managingvery complexquality issues including escalations within the Company and with Customers. This includes direct verbal interactiondocumented communications (email letters PowerPoint)and issuing written reports

• Knowledge ofCompliance with quality standards (e.g. 21 CFR Part 820 ISO)

• Experience with the use of key quality toolse.g.FMEA Risk AnalysisRCAand globalsystemse.g.TrackWise AGILE E1/SAP LIMSor similar

• Training/understanding in Lean Sigma/Six Sigma processes

PreferredKnowledge Skills Abilities

• Experience within the pharmaceutical and/or biotechnology industry either in a customer-facing role or as an end-user of bioprocessing technologies; mustdemonstratestrong understanding of customer quality regulatory and operational expectations and familiarity with purification and/or pharma analytics products and their application in pharma/biotech environments

• Knowledge of procurement/supplier oversight

• Experience in project management

• Understanding of Lean Production System concepts

• Regulatory Affairs Experience and/or RAPS Certificationor ASQ Quality Certificationswould be a plus