Quality Director, Single-Use Division

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them.

How will you make an impact?

Reporting to the Sr. Director of the Bio-Production Group (BPG), this role will be responsible for building a customer-focused quality culture and associated processes. This includes a dedication to optimizing the customer experience through customer feedback and delivering products that represent industry-leading standards of product quality. Ensuring quality in our products is vital to fulling our company mission to “enable our customers to make the world a healthier, cleaner, safer place.”

Location/Division Specific Information

This role is part of the Bioproduction Quality Group. Role is located at any of our SUD major Bioproduction sites (Logan/SLC, UT; Millersburg, PA; Nashville, TN; Cramlington, UK). Remote location can be considered

What will you do?

• Defines the Quality strategy for the Single-Use products in alignment with Group and Goals of the company. Ensures adequate deployment and execution of such strategy
• Provides Quality leadership for the SUD multi-site network (8 sites globally).
• The position is encouraged to be customer facing, building professional relationships with his or her Quality counterparts within the customer organizations
• Leads matrix relationships within Thermo Fisher to ensure all product value stream touch points are aligned to deliver Quality products and processes
• Drives 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
• Provides training, mentors, and coaches team members and peers
• Applies Quality Risk Management to prevent risk of failure modes that impact supply of consistent supply of Quality SUD products
• Conducts advanced data analyses to resolve quality problems and to identify larger scale quality improvements. An adequate sense of urgency is expected
• Participates in cross functional team projects (R&D, Mfg, Vendors, etc). Examples: support new SUD product introduction projects, or quality improvement projects - identify root cause of product specific defects and apply a risk management approach to mitigate risk of Quality issues throughout the product life cycle value stream

How will you get here?

Education

• Bachelor’s degree or above in Science, engineering subject areas 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 running/leading a multi-site organization
• Audit (ISO13485 or similar) or inspection (FDA or similar) management experience
• Customer facing experience

Knowledge, Skills, Abilities

• Experienced knowledge of Quality Management System design and oversight from a pharmaceutical perspective and/or medical device field
• Strong communication skills, written and verbal. Experience leading very complex quality issues including partner concerns within the Company and with Customers. This includes direct verbal interaction, detailed 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

• Competency of Single-use technology and capabilities, pharmaceutical production, pharmaceutical new product or medical device introductions
• 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

Our global team of more than 90,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

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.