Director – Quality Purification, Pharma Analytics

Thermo Fisher Scientific

Director of Quality leading strategic quality initiatives within the Pharmaceutical field at Thermo Fisher Scientific. Responsible for building a customer-focused quality culture and optimizing customer experience.

Posted 5/6/2026full-timeBedford • Massachusetts • 🇺🇸 United StatesLead💰 $160,100 - $240,125 per yearWebsite

About the role

Key responsibilities & impact

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
Partner 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
Participate in cross functional team projects (R&D, Mfg, Vendors, etc)

Requirements

What you’ll need

Bachelor’s degree or above in Science, engineering disciplines or similar fields
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
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
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

Benefits

Comp & perks

A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Management System designQuality Risk ManagementData analysisFMEARisk AnalysisRoot Cause Analysis (RCA)Lean SigmaSix SigmaAudit managementInspection management

Soft Skills

LeadershipCommunicationProblem-solvingAnalytical skillsCreativityJudgmentChange managementCustomer engagementCollaborationInterpersonal skills