Position Summary:

The Manager, Supplier Quality is responsible for the implementation, management and sustainment of the Thermo Fisher Quality Management System with respect supplier quality to ensure conformity with US FDA, EU, ISO and other applicable quality and regulatory requirements as it applies to the manufacturing of raw material used in the production of pharmaceutical and biopharmaceutical products. This position will also support the Director, Quality Management System with other Quality Management elements as required.

Key Responsibilities:

• Ensure that the quality system is implemented at all levels within the organization to meet all applicable regulatory requirements, including but not limited to FDA EU, ISO.
• Develop and Implement a supplier audit program, including contract manufacturers and out-sourced packaging.
• Conduct contract negotiations, including quality agreements and ensures implementation of agreed-upon requirements for all contract manufacturing.
• Develops labeling, product and process specifications in collaboration with Marketing, R&D, Product Development and other stakeholders.
• Reviews and approves all specifications for suppliers and contract manufacturers, including finished, intermediate, raw material, labeling and process specifications. Maintains a document control process to ensure revision control.
• Develops and implements a ship-to-control (STC) system, including identification of Key Process Indicators (KPIs) for all processes, KPI monitoring, investigation of OOC/OOS batches and disposition.
• Maintains a Supplier Quality Management Program, including establishment of key performance indicators and quarterly monitoring of suppliers against those indicators (quality, on-time delivery, SCARs, regulatory findings, etc). Reports on supplier performance to management.
• Oversees supplier deviations, non-conformances and supplier corrective actions (SCARs) including review and approval of proposed actions. Ensures agreed upon containment, corrective and preventive actions are effectively implemented through established monitoring systems and the supplier audit program.
• Establishes and maintains a change notification process with all suppliers and contract manufacturers.
• Ensure all related supplier regulatory documentation is appropriate and maintained according to established document control procedures.
• Responsible for the review of all batch records, incoming inspection, intermediate and finished product SOP’s for compliance to regulatory and Thermo Fisher requirements.
• Represents Supplier Quality in external and internal audits
• Develop and implement systems to measure and increase quality in all areas to assure regulatory compliance.
• Utilizes 6-sigma and LEAN tools to improve processes and reduce waste throughout the Quality Management System.
• Responsible for managing, coaching, and developing team members and suppliers in aspects of Thermo Fisher regulatory and quality requirements and practices.

Other duties as assigned

Minimum Requirements/Qualifications:

• Minimum of 5 years’ experience within the Pharmaceutical or Pharmaceutical Industry supporting Regulated Products.
• Minimum of 3-5 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, the Commercial Team and Customers.
• 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 and regulations (e.g., 21 CFR Part 210,211, ISO 9001) and Quality Management System design and oversight from a Pharmaceutical perspective.
• Compliance with quality standards ((e.g., 21 CFR Part 210, 211, ISO, 9001)
• Quality tools e.g. FMEA, Risk Analysis, RCA, Change Management
• Global Systems e.g. TrackWise, AGILE, E1/SAP, LIMS

Non-Negotiable Hiring Criteria:

• Bachelor’s degree from accredited college/university or equivalent experience with a preference for Science, Engineering, or specialty Biomedical Engineering
• Strong written and verbal communication skills with effective strategies for interacting with a variety of audiences and situations
• Proficient computer skills including email, word processing, spreadsheets, database and internet applications
• requires 25%-50% travel