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.
• Provide quality leadership for the Cell Culture segment with matrix engagement into the global Bio Production Quality Network partnering with operations and commercial organizations for harmonization of processes and aligning business synergies at the Grand Island, NY manufacturing site.
• Visible Quality Leader of the ISO 13485 Quality Management System with FDA registered manufacturing facility of Class 1 and Class 2 Devices (21 CFR part 820). Responsible for assuring internal policies, customer expectations, and regulatory requirements are met.
• Change Leader driving a culture of continuous improvement by employing Practical Process Improvement concepts and managing metrics, tier system escalations, reporting and communicating internally to Senior Leaders and diverse audiences.
• Closely partner with key pharmaceutical customers to adopt the management system and manufacturing methods to meet aseptic manufacturing standards and applicable 21 CFR part 210/211 and EU requirements.
• ISO Management Representative of the site Quality Management System driving effective Management Reviews, Complaint Handling, CAPA system, Change Control, Calibrations Maintenance, Validation, Internal Auditing, Training, R&D Transfers, and Manufacturing Area Support.
• Supports complex, cross-functional quality issues in a variety of subject matter areas (e.g. biology, electrical, mechanical, chemistry and software) and drives resolution and proactive solutions to customer complaints (functional defects with components or performance related failures), backorder issues, and disposition of materials.
• Actively manage the Quality Control team performance to meet standard turnaround times. QC test first pass yield (test/retest error), and labor efficiency.
• Closely partner with the Global Design Quality Assurance organization to drive robust design transfer and long term new product introduction success.
• Set site wide QA/QC priorities and key objectives to reduce the cost of poor quality and improve the compliance to regulations and the site Quality System.
• Ensure site wide training is effective and that the plant operates within the required regulatory guidelines by examining and testing plant-wide processes and products from a final product acceptance and compliance perspective.
• Provide significant knowledge and insight into qualification and validation activities and the ability to work effectively with engineering and operations teams in completing these tasks.
- Bachelor’s degree from accredited college/university or equivalent experience with a preference for Science, Engineering, or specialty Biomedical Engineering.
- Minimum of 15 years’ experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products.
- Minimum of 10 years of management experience in a complex, biopharmaceutical manufacturing environment.
- Excellent communication, collaboration and interpersonal skills with the ability to facilitate team interactions and to partner with and influence key stakeholders including Finance, R&D, Product Management and the Commercial team.
- Strong leadership ability with the capability to leverage and flex diverse resources, respond quickly, understand the impact of changes and decisions, facilitate agreement, build collaborative relationships and focus on customer needs.
- Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency. Lean Six Sigma Black Belt or trained in Lean Sigma/Six Sigma processes.
- Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
- Expert knowledge of quality standards (e.g., 21 CFR Part 820, ISO 13485 9001 regulations) and Quality Management System design and oversight from a Medical Device or Pharmaceutical perspective.
- 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 software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (Agile, Trackwise, LIMS, Master Control, ERP, etc.).
- Bachelor’s degree in Engineering, Chemistry, Biology or Biomedical Engineering
- Experience with Cell Culture manufacturing (dry and liquid) or other similar biological processes. Project Management advanced experience.
- Certified Lean Professional or Six Sigma Black Belt