Manager, Quality

at  Thermo Fisher Scientific

JOB DESCRIPTION

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

EDUCATION:

• Minimum required education: Bachelor’s degree in Chemistry, Biology, Biochemistry, or Environmental Sciences. Equivalent experience in the field will also be considered.

EXPERIENCE:

• Minimum of 6 years of experience in quality assurance / quality control with direct supervisory responsibilities.
• Experience with Compliance & Quality standards (e.g., 9001, 21 CFR, GxP)
• Broad/well-rounded process knowledge including validation
• Multi-site/Global software programs experience
• Quality tools e.g. FMEA, Risk Analysis, RCA, Analysis, etc.

KNOWLEDGE, SKILLS, ABILITIES:

• Candidate will work independently, as well as, on teams within the site (Procurement, Sales, Production Ready Services and Operations).
• Multitasking ability in a fast-paced environment and flexibility in prioritizing work.
• Excellent written and oral communication skills are required.
• Accuracy and attention to detail is required in performing all functions of this position. Initiative, interpersonal and digital literacy are very valuable.
• Candidate must be customer centric; Must demonstrate judgment, tact, and subtlety in dealing with internal and external customers.
• Works in a team-oriented environment in order to support all daily functions of the global sites.
• Must possess self-motivation and the ability to work on routine analysis with no instructions or new assignments with limited instructions.
• Work safely with chemicals, biologics and hazardous materials.
• Global Systems e.g. TrackWise
• Travel up to 20% of the time.
  Our Mission is to help our customers create a healthier, cleaner, and safer world. Take a look at our colleagues’ video where they discuss why it’s great to work with us. At Thermo Fisher Scientific, we have a team of 100,000 colleagues working together to solve scientific challenges, accelerate research, drive innovation, and support patients in need. Join us and #StartYourStory, where we value diverse experiences, backgrounds, and perspectives.

• Ensure the cleanrooms are maintained and certified to meet industry standards and the requirements of customers
• Provide commercial support and be a customer facing authority by working closely with customers on implementation of quality related services and capabilities through customer meetings, presentations and timely follow-up.
• Develop the required processes and systems and write and follow standard operating procedures related to the raw material sampling, validation, and complaint functions and other cGMP quality related services and capabilities as needed to support customer requirements and expectations.
• Leads teams within PCS and BPG to build and/or modify processes and procedures to ensure that appropriate processes are developed to meet required customer and regulatory standards.
• Management of the validation master plan, as well as, assuring that processes and procedures ensure appropriate validation is being conducted throughout the organization including warehouse temperature mapping, computer system validations(CSV), and cleanroom validations.
• Ownership of the complaint processes within the organization. Drives appropriate action and brings supplier complaints to closure.
• Perform statistical analysis to analyze trends, and works to investigate, conduct root cause analysis, and recommend corrective actions for processes and products. Tracks data to support site level metrics (e.g. CAPA, complaints and on-time sampling)
• Works directly with customers on critical sampling and inspection processes. May lead issue/complaint resolution when root cause is traced to sampling and inspection processes
• Seen as subject matter authority supporting sampling and inspection, validation, and complaint management.
• Ensures overall program and product quality improvement by leading cross-functional teams in continuous process improvement implementing preventative actions and reviewing lessons learned