Assoc Dir QA Med Device/Combination Products

Assoc Dir QA Med Device/Combination Products

Regeneron

Limerick, Ireland

Position Summary:

Provide QA oversight of the Medical Device/Combination Products including pre-filled syringe and auto-injectors/pen injectors for biological therapeutics developed in-house and in collaboration with partners and CMO’s. Supports the work of Industrial Operations and Product Supply (IOPS) sites through the use of quality risk management principles and their application to medical device development and commercialization. The scope will involve collaboration with partners and their respective programs, focused on development, post transfer and commercial activities.

Essential Duties and Responsibilities include, but are not limited to, the following:

  • Provide leadership to the Medical Device Quality Oversight team. Implement and maintain the Quality Management System ensuring compliance to all applicable combination product/medical device regulations;
  • Provide Quality Assurance oversight for the Combination Product Development function;
  • Provide guidance and participate in Design Development, Design Transfer, and Commercialization reviews and activities; and where appropriate in Feasibility, Development, Design Verification, Design Validation activities associated with combination products;
  • Function as the primary interface for QA advising on combination products quality issues within the IOPS organization. Work effectively and influence multiple functions (Combination Product Development, Operations, Commercial, Regulatory, Supply Chain, etc.) to ensure quality requirements are met;
  • Manage and lead data driven risk assessments (risk identification, analysis and ranking). Educate and train staff (cross sites) to update and maintain medical device quality risk management as part of lifecycle management;
  • Lead quality system improvement initiatives;
  • Assure integration of device, drug and biologic regulations into quality system;
  • Provide technical support to quality engineers and regulatory team for technical filings and updates;
  • Represent Regeneron’s QMS during regulatory inspections and partner audits;
  • Interact with partners and contract organizations to ensure timely completion of project milestones, including impact of changes and post-commercialization activities;
  • Perform 3rd party management activities such as review of design control deliverables, assessment of supplier changes, supplier controls (corrective actions), quality agreements, relationship development, etc.;
  • Approximately 30% travel.

Education and Experience:

  • Requires BS/BA in Life sciences or B. Engg. in Mechanical or Biomedical engineering (or equivalent), Master’s degree a plus;
  • Minimum of 10 years of experience in the pharmaceutical/medical device/biotechnology industry (biotech with combination product experience preferred);
  • Proven experience in global applications of Quality Risk Management and Quality Assurance in the medical device field at a multi-site level;
  • Device regulation (design control) experience required;
  • Combination product and experience with supplier management preferred;
  • Leadership of other technical professionals and experience in leading global cross-functional teams with results-orientation;
  • Skilled in the initiation, selection, coordination and management of projects and have ability to resolve unusually complex technical problems by providing solutions that are highly innovative;
  • Knowledge of regulations and standards affecting devices, biologics and pharmaceutical products;
  • Knowledge of ISO standards, US Code of Federal regulations, and the EU regulations;
  • Conflict resolution skills including persuasive management techniques required;
  • Strong oral and written communication skills needed;
  • Excellent interpersonal skills required;
  • Makes critical, creative and strategic decisions as a result of rapid analysis of available information including risk-assessment for the patient and for the business;
  • Must be able to respond quickly to unplanned events, technical issues and changing needs from development programs by making sound quality judgment from complied factual data provided by the different functional areas, each presenting varied viewpoint of regulatory requirements or project needs and requirements;
  • Must have experience working with all levels of the organization including engineers up to Senior Leadership.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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