Sr Manager, Quality Assurance - Medical Device/Combination Products

Sr Manager, Quality Assurance - Medical Device/Combination Products

Gilead

Cork, Ireland

You will be the key QA person supporting new and existing combination product lines in both clinical and commercial stages.

Roles/Responsibilities:

  • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements, such as ISO 13485 and ISO 14971;
  • May manage QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews;
  • Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, , etc.) as needed to ensure defined quality objectives are met;
  • Implements and maintains programs and processes to ensure high quality products and compliance with applicable medical device and combination product requirements.
  • Responsible for final release of manufactured products;
  • Works extensively with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications;
  • May participate in the writing of annual product reviews, assess changes and product complaints against the DHF and RMF and the development of training programs regarding all aspects of producing quality products.;
  • Provide guidance and impact assessments for Change Control, including DHF/RMF/Tech File assessments;
  • Serves as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products. May lead compliance audits as required;
  • Interfaces with contract manufacturers to address and resolve more complex product/process performance issues;
  • Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes;
  • May interface with regulatory agencies as required;
  • Serves as a project lead within the function.

Key Contributions:

  • Determines corrective action on investigative findings and with consideration of the long-term impact of decisions;
  • Works on problems that are moderately complex in scope where analysis of situations or data requires in-depth evaluation of various factors. Considerable judgment is required in resolving problems and making routine recommendations;
  • Exercises judgment within defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results;
  • Provides final lot release approval;
  • Interfaces with contract manufacturers to address and resolve more complex product/process performance issues;
  • Co-hosts external audits and interacts closely with external regulators/stakeholders.

Knowledge, Experience, and Skills:

  • Relevant years of experience in a GMP environment related field and a BS or BA;
  • Extensive knowledge of FDA/EMEA and other global regulatory compliance guidelines for medical devices and/or combination products. Knowledge of drug manufacturing, packaging, and distribution not required, but a plus;
  • Demonstrates in-depth knowledge of GMPs;
  • Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards;
  • Demonstrates excellent verbal, written, and interpersonal communication skills;
  • Demonstrates keen understanding of international quality systems regulations to adopt best in class systems/processes, and drive continuous improvement initiatives;
  • Demonstrates knowledge of Information Systems Technology current electronic records and signature requirements;
  • Knowledge of ISO 14971 Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and/or Failure Mode Effects Analysis (FMEA)) is preferred;
  • Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred;
  • Certification by ASQ (such as CQA, CQE, or CQM) or other industry-recognized professional organizations is preferred.

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© EuroJobsites 2022

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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