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Sr. Director Bio Production

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 #1769 or a link to this job.

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