When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

How will you make an impact?

The Director of Quality for Purification and Analytics will report into the Sr. Director of Quality for the Bioproduction division and will be responsible for management of the Quality operations made up of multiple sites within the division (Bedford, Massachusetts and Naarden, Netherlands) and shared sites within Thermo fisher that manufacture products for the Bioproduction division (Warrington, UK and Pleasanton, California). This position will manage both direct organizational reports and matrix reporting quality personnel to insure compliance with industry and regulatory standards and customer expectations for purification and analytical products used in pharmaceutical manufacturing. The person in this role will have reporting to them two Quality site heads and will determine, organize and apply necessary resources that enable key Quality initiatives and insure that Corporate, Regulatory, and Quality requirements are met. As the Head of Quality for this business unit, the role will also focus on insuring that staff engagement is maintained at a high level through development planning, Gemba, skip level, and 1:1 meetings.

This position is responsible for Quality as applied to products used for Purification and Analytical Method Validations, Documentation Management, Quality Control, Change Control, Auditing, Supplier Quality, and other Quality Management processes that insures a consistent supply of fit for purpose products to a variety of customers from research to pharmaceutical production. This role will report into the Bioproduction Quality organization from a strategic and tactical perspective and is responsible for driving the overall culture of compliance within the Pharma- Purification and Analytics teams. The Pharma-Purification and Analytics business is a dynamic unit that innovates and commercializes state of the art purification and analytical solutions for Pharmaceutical manufacturing and Quality and safety testing used in Microbiology, Analytical Sciences, Analytical Development, Protein Chemistry and Quality Control.

What will you do?

• Provide Quality leadership for the Pharma-Purification and Analytics Network
• Responsible for Quality oversight across multiple sites based the organizational design that spans multiple countries
• Contribute to the strategy and development of the Quality Management System for the Pharma-Purification and Analytics organization
• Partner with the operations and commercial organizations to ensure customer fulfillment
• Manage matrix relationships to ensure compliance of the network
• Deploy key programs to ensure alignment of the organization to agreed goals
• Work across multiple product lines and types of manufacturing processes seamlessly
• Solve problems in complicated situations using analytical skills, creativity, and judgment
• Impact through delivery of results
• Communicate internally to senior leaders and diverse audiences
• Complete assignments of diverse scope and complexity
• Provide training, mentor, and coach team members and peers
• Drive resolution to quality complaints (functional defects with components or performance related failures), and applies Quality Risk Management to prevent risk of consistent supply of critical reagents and instrumentation to customers
• 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.). Examples: support new 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 and Quality built in to the product concept
• Determine clarifications and compliance to written standards (e.g. ISO, FDA part 11), providing additional information for the site to ensure consistent application of quality processes
• Ensure overall program and product quality improvement by guiding other team members in continuous process improvement implementing preventative actions and reviewing lessons learned

How will you get here?

Education

• Bachelors degree or above in Science or Engineering Disciplines

Experience

• 10 years’ experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products

Knowledge, Skills, Abilities

• Expert knowledge of Quality Management System design and oversight from a Medical Device or Pharmaceutical perspective
• Knowledge of:
  • Compliance with quality standards (e.g., 21 CFR Part 820, ISO 13485, 9001)
  • Quality tools e.g. FMEA, Risk Analysis, RCA
  • Global Systems e.g. Track Wise, AGILE, E1/SAP, LIMS
• Proficient in Computer applications and current software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (Agile, Track wise, LIMS, Master Control, ERP, etc.)
• Training in Lean Sigma/Six Sigma processes
• Ability to travel and interface with external customers and commercial teams

Preferred Knowledge, Skills, Abilities

• Support of Medical Device or Pharmaceutical New Product Introductions.
• Strong competency in Quality Control methods and validations.
• Multilingual
• Knowledge of procurement/supplier oversight.
• Experience in project management.
• Regulatory Affairs Experience and/or RAPS Certification would be a plus

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.