All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.
If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.
Reporting to the Sr. Director of the Bio-production division, the Director of Quality for the SUT business unit is responsible to insure that a consistent supply of Quality product to customers is fully realized. The person in this role is responsible for the strategy, implementation & leadership of the Quality function within the Single Use Technology (SUT) business unit and is accountable to a team of expert Quality site leaders to insure they have what is needed for the execution and administration of the GXP Quality System aligned to the division. This role will encompass all aspects of the Quality management system from strategic planning to hands-on implementation where needed on topics of Quality Assurance/Control, auditing, document management, CAPA, complaint management, as examples. Through partnership and direct accountability this role is expected to be the agent to facilitate a Quality culture and process execution throughout the entire SUT product value stream; i.e., development, manufacturing, procurement, through to release and shipment to customers. Expectation is that this role be customer facing, to build relationships with Quality counterparts within our customers organizations for transparency and partnership helping to insure goals are met for our customers drug supply to patient.
- Provides Quality leadership for the SUT multi site Network.
- Responsible Quality oversight across 4+ Sites based on the organizational design that spans multiple countries.
- Contributes to the strategy and development of an aligned BPD Quality Management System used for SUT products.
- Partners with the operations and commercial organizations to ensure customer fulfillment.
- The position is expected to be customer facing, building professional relationships with his or her Quality counterparts within the customer organizations.
- Manages matrix relationships within Thermo fisher to ensure all product value stream touch points are aligned to owning Quality of our products.
- Deploys key programs to ensure alignment of the SUT business unit to agreed to goals.
- Solves problems in complicated situations using analytical skills, creativity, and judgment, and technical expertise with the SUT technology.
- Impacts through delivery of results.
- Communicates internally to senior leaders and to diverse audiences.
- Completes assignments of diverse scope and complexity.
- Provides training, mentors, and coaches team members and peers.
- Drives resolution to quality complaints (functional defects with components or performance related failures),
- Applies Quality Risk Management to prevent risk of failure modes that impact supply of consistent supply of Quality SUT products.
- Conducts advanced data analyses to determine quality problems and to identify larger scale quality improvements.
- Participates in cross functional team projects (R&D, Mfg, Vendors, etc). Examples: support new SUT 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.
- Determines 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.
- Ensures overall program and product quality improvement by guiding other team members in continuous process improvement implementing preventative actions and reviewing lessons learned.
• Bachelor’s degree or above in Science or Engineering Disciplines.
• 10 years or more experience within the Pharmaceuitcal Industry - supporting Regulated Products.
• Expert knowledge of Quality Management System design and oversight from a Pharmaceutial perspective and/or medical Device field.
- 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. TrackWise, AGILE, E1/SAP, LIMS
- Proficient in Computer applications and current software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (Agile, Trackwise, LIMS, Master Control, ERP, etc.).
- Training/understanding in Lean Sigma/Six Sigma processes.
- Competency of SUT 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 would be a plus
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and approximately 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.