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Bedford, Massachusetts, USA, United States of America
Onsite
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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 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
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