Director, Quality Purification and Pharma Analytics

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 communicate 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.

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
• Retail 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: here.