Director, Quality Purification and Pharma Analytics

ThermoFisher Scientific; Bedford (MA); On-site; USD 160,000 - 240,000; Full time

Job summary

Thermo Fisher Scientific in Bedford, MA is seeking a Director of Quality to lead strategic quality initiatives across the PPA network, aligning with group and corporate goals. You will drive a robust quality culture, manage multi-site relationships, and partner with SMEs to deliver industry-leading product quality.

The role focuses on preventing risk with Quality Risk Management, data-driven problem solving, and cross-functional collaboration with R&D, Manufacturing, and Vendors to ensure

Qualifications

• Bachelor's degree or higher in Science, engineering disciplines or similar fields.
• 10+ years of experience in 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.

Responsibilities

• 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.
• Apply Quality Risk Management to prevent risk of failure modes that impactsupply 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).

Skills

Quality leadership

Regulatory knowledge

Quality management

Cross-functional collaboration

Communications

Lean Sigma/Six Sigma

Audits/Regulatory inspections

Procurement oversight

Education

Bachelor's degree

Tools

TrackWise

AGILE

E1/SAP

LIMS

Job description

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 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).

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 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

• 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

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

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.