Global Quality Leader – BioProduction Network

  •   Full Time
  •   Buffalo

Responsibilities:

  • Provides leadership for the global BioProduction Quality Network.
  • Responsible for 15+ Site Based Quality Organizations across the world.
  • Contributes to the strategy and development of the Quality Management System.
  • Partners with the operations and commercial organizations to ensure customer fulfillment.
  • Manages matrix relationships to ensure compliance of the network.
  • Deploys key programs to ensure alignment of the organization to agreed goals.
  • Creates, enhances, and sustains compliance systems for registered medical devices and pharmaceutical products.
  • Works across multiple product lines and types of manufacturing processes seamlessly.
  • Solves problems in complicated situations using analytical skills, creativity, and judgment
  • 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.
  • Supports complex, cross-functional quality issues in a variety of subject matter areas (e.g. biology, electrical, mechanical, chemistry and software).
  • Drives resolution and proactive solutions to quality complaints (functional defects with components or performance related failures), backorder issues, and dispositioning of materials.
  • Conducts advanced data analyses to determine quality problems and to identify larger scale quality improvements.
  • Provides quality specific training and guidance to the organization (e.g. Six Sigma Black belt program) to correctly identify and define quality problems early.
  • Participates in cross functional team projects (R&D, Mfg, Vendors, etc). Examples: support new product introduction projects, or quality improvement projects – identify root cause of product specific defects.
  • Determines clarifications and compliance to written standards (e.g. ISO), 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.

Minimum Qualifications:

  • Bachelor’s degree in Science or Engineering Disciplines.
  • 10 years experience within the Medical Device or Pharmaceuitcal Industry supporting Regulated Products.
  • Expert knowledge of Quality Management System design and oversight from a Medical Device or Pharmaceutial perspective.
  • 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 in Lean Sigma/Six Sigma processes.

Preferred Qualifications:

  • Support of Medical Device or Pharmaceutical New Product Introductions.
  • Strength in the Cell Culture/Microbiology area.
  • Strong competency in Quality Control methods and validations.
  • Multilingual
  • Experience in procurement/supplier oversight.
  • Experience in project management (PMP certification)
  • Regulatory Affairs Experience and/or RAPS Certification

For immediate consideration, please forward a copy of your current resume to info@profrecruiters.com referencing job #1719 or a link to this job.

Job & Company Detail

Company Industry

Architect Industry

Company Size

1 - 9 Employees

Language

English

Job Category

Bio Technology, Lab / Science

Applications Accepted Until

01 January 2030

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