Director, Quality Purification and Pharma Analytics

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 intensity a robust quality culture across the organization 

• Provide Quality leadership for the PPA multi-site network.  

• Manage matrix relationships within Thermo Fisher 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, engineering disciplines 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 pharmaceutical perspective and/or medical device 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 quality tools e.g. FMEA, Risk Analysis, RCA and global systems 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 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 Certification or ASQ Quality Certifications would be a plus