Boston Scientific is looking to improve the performance of active pharmaceutical ingredients (API), excipient suppliers and increase the supplier's capabilities to consistently meet Boston Scientific's requirements.
Requirements
- Strong knowledge of FDA 21 CFR 820 and CFR 210/211.
- Ability to work in a matrixed environment.
- Experience in pharmaceutical or drug combination products.
- Experience with manufacturing support or process development (preferred).
- Experience with project management (preferred).
- Ideally someone with experience in aseptic processes (preferred).
- Experience in global supplier management, ISO 13485, ISO 9001 (strongly desired)
Responsibilities
- Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including audit scheduling, investigation, and evaluation of audit observations and findings, reporting, follow-up, and confirmation of follow-up actions.
- Develops solutions to complex problems by evaluating data and selecting methods within defined practices and policies.
- Communicates quality issues to suppliers, applies systematic problem-solving methodologies, and reviews and approves supplier corrective action plans and effectiveness documentation.
- Actively engaging in Global Sourcing category teams as a technical lead, establishing and executing Global Sourcing category objectives
- Leads cross-divisional and cross-functional projects that deliver improvements to quality systems and processes.
- Works under minimal direction regarding the direction and progress of projects and special assignments.
- Establishes and cultivates a wide range of business relationships to facilitate completion of assignments.
Other
- BS degree in Chemistry, Biochemistry, chemical engineering or similar with minimum of 5 years of relevant experience.
- Communicates effectively and concisely pack up information to deliver key points; appropriately scales communication style and depth according to the audience.
- Ability to influence cross functional global teams spanning Design Quality Assurance, R&D, Regulatory, Supplier Engineering, and Sourcing.
- Travel up to 10% of the time.
- Ability to work independently and collaborate with project teams; organized and self-driven.
