Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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. Thisrole willbe responsible forbuilding a customer-focused quality cultureand associated quality processes This includes a dedication tooptimizingthe customerexperience through customer feedback and delivering products thatrepresentindustry-leading standards of product quality.

Location

This role is part of the Bioproduction Group within the Purification and Pharma Analytics business unit and islocatedat the 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&D,Mfg, Vendors,etc).

How will you get here?

Education

• Bachelor’s degree or above inScience,engineeringdisciplinesor similar fields

Experience

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

• At least 5 years of experience managingleadingamulti-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

• Businessexpertise,understandhow 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 interaction,documented communications (email, letters, PowerPoint),and issuing written reports

• Knowledge ofCompliance with quality standards (e.g., 21 CFR Part 820, ISO 13485, 9001)

• Experience with the use of key quality toolse.g.FMEA, Risk Analysis,RCAand globalsystemse.g.TrackWise, AGILE, E1/SAP, LIMSor 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; 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

Compensation and Benefits

The salary range estimated for this position based in Massachusetts is $160,100.00–$240,125.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• 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

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards