Singapore Commercial Quality Assurance

2 weeks ago

Central Singapore Abbott Laboratories Full time
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

Our rapid diagnostics solutions are helping address some of the world's greatest healthcare challenges.

RESPONSIBILITIES:

  • Hold accountability of Competent Technical Staff for ARDx Products as per the Local Regulations and ensure that ARDx operations meet all the Quality and Compliance obligations as required for the Importation and Distribution license.
  • Accountable for being Management representative with Responsibility & Authority for the Quality and Regulatory requirements; ensuring compliance to Abbott Global Quality/Regulatory Framework and Divisional Policies/ Procedures.
  • Take full ownership of managing Quality Inspection of Imported ARDx Products, their release in the ERP system, storage and Distribution from Quality perspective.
  • Conduct gap analysis of local operations/practices/activities against ARDx Divisional QMS Policies/Procedures/Local regulations and develop/update the SOPs as needed and deploy the same for daytoday governance.
  • Lead the Preparedness of Local Health Authorities, ARDx Divisional, Notified Body, and AQR Global Audits and manage them end to end including CAPA followups and closures.
  • Conduct a Quarterly Quality System Management Review covering ARDx Products as mandated by Global Abbott Quality & Regulatory.
  • Lead the Quality Issues/Quality data requests/Recalls/FCA by engaging with involved Legal Manufacturers of ARDx products.
  • Compile and report quality data/metrics and lead Quality Improvement Initiatives.
  • Lead the deployment of Agile System in the affiliate for ARDx and ensure that all the NC/CAPA/ Document Management System are managed in Agile Product Lifecycle management.
  • Oversee Quality Complaints for Abbott products, ensuring timely investigation, resolution, closure & customer followups. Proactively reviewing product complaints and address the trends in a timely manner
  • Provide relevant quality support for post market surveillance (PMS) activities.
  • Conduct documented Quality Risk Assessment of the situations as they may arise and obtain approvals.
  • Responsible for administration of and compliance with all major quality system activities including but not limited to document control, record control, training, CAPA, quality incidents, risk management and internal audit. Review/Approve Changes, Deviations, Investigations, Market Complaints & CAPA.
  • Represent commercial leader in areas of quality decisions, such as escalations, field actions and/or other significant quality issues.
Regional Quality System and Documentation Support

  • Works with the Regional Quality Systems lead to support on the Quality Systems governance in the APAC region.
  • Responsible for supporting the documentation in the region and driving compliance to Good Documentation Practices.
  • Responsible for supporting the implementation of Electronic Document and Quality Management systems like Agile and administer/champion the same in the region.

Requirements:

  • Bachelors Degree in Pharmacy/Science/Engineering
  • Minimum 8 years of experience in Quality Assurance and/or Compliance in healthcare (diagnostics/medical devices/pharma) or regulated industry
  • Strong analytical, communication, decisionmaking and leadership skills for interaction with external and internal customers and partners.
  • Strong ability to negotiate with stakeholders.
  • Able to manage multiple priorities and pull information together from multiple business units to ensure concise consolidated business picture is communicated to the commercial businesses.
  • Superior attention to accuracy and details.
  • Strong English verbal and written communication skills with the ability to convey appropriate information with clarity and effectiveness.
  • Strong knowledge of relevant medical device industry regulations for quality systems and compliance.
  • Ability to work effectively within a team in a fastpaced changing environment. Multitasks, prioritizes and meets deadlines in timely manner.
  • Experienced in conducting and handling audits and inspections.


Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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