Head of Commercial Quality – East Asia

3 days ago

Shanghai, Shanghai, China Abbott Laboratories Full time
PURPOSE:
  • This position will provide Commercial Quality Leadership to Mainland China, Hong Kong, Macau, and Mongolia markets, South Korea, and Taiwan in Abbott Rapid Diagnostics business. The above area/cluster is a set of diverse markets with varied customer segments and has the largest number of distributors in Asia Pacific.
MAJOR RESPONSIBILITIES:
  • Accountable for being Management representative with Responsibility & Authority for the Quality and Regulatory requirements; ensuring compliance to Abbott Global Quality/Regulatory Framework, Divisional Policies/ Procedures.
  • Responsible for proactively creating Quality Culture w.r.t People, Process, Products & Services to meet customer needs.
  • Maintain QMS in the market and continually evaluate and monitor the quality system for suitability and adequacy for the commercial business.
  • Must interface and represent commercial leader in areas of quality decisions, such as escalations, field actions and/or other significant quality issues.
  • Engage as required for the Quality Complaints for Abbott products, ensuring timely investigation, resolution, closure & customer follow-ups through the Legal Manufacturers and Tech Support Team. Proactively reviewing product complaints and address the trends in a timely manner.
  • Collaborate with other global entities in fulfilling Field Corrective actions (FCA) resulted from Regulatory Field Safety Notifications.
  • Provide relevant quality support for post market surveillance (PMS) activities, ensure timely executions to minimize, any product supply interruption.
  • Facilitating Audits (Corporate Quality Audits, Regulatory Audits, ISO-Notified Bodies)
  • Ensuring implementation of effective CAPA program across operational site.
  • Driving Supplier Qualification Program (Identification, Evaluation through Audits, Monitoring, Maintenance & Re-Qualification).
  • Review/Approve Changes, Deviations, Investigations, Market Complaints & CAPA.
  • Responsible for Budgetary Planning for Quality Operations.
  • Evaluate the existing Quality Management System implemented in the country with the Abbott QMS and Business Unit Quality Standards and Procedures and conduct gap analysis , develop a remediation plan and drive it to achieve highest level of compliance.
  • Responsible for the Quality Control program for imported products that are distributed in the market
  • Has final decision making responsibility for product release.
  • Has final decision making and reporting responsibilities for field corrective actions.
  • Collect information on product quality and when concerning information is obtained, provide timely written report to appropriate management so that necessary and appropriate measures be taken.
  • 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.
  • Continuously drive for compliance with Abbott quality standards and regulatory requirements.
  • Responsible for management and satisfactory resolution of product issues in a timely manner. Coordinate cross-functionally to ensure implementation of containment, mitigation, remediation and corrective activities as necessary.
  • Coordinate with entity management and facilitate Quality Management Review activities, including quarterly quality objective reporting, escalation of issues with QMS impact and closure of open actions from previous meetings.
  • Responsible for coordination and management of site Quality metric tracking, trending and reporting activities. Assure metrics appropriately characterize the key performance indicators of the quality system.
  • This position will be the Commercial Quality representative for internal compliance and 3rd party audits / inspections. Coordinate and manage all commercial audits in conjunction with the Commercial office lead.
  • Implement new or modify existing processes to maintain compliance with local entity, business unit, division, corporate, voluntary standards and regulatory requirements.
  • Develop Commercial Quality team in the Cluster and the talent pool and ensure capabilities are in place to become self- sufficient in the necessary aspects of Quality.
  • Implement Talent Strategies to grow quality capabilities, provide development opportunities for key talent, and drive a global mindset within the cluster.
  • Other duties as assigned.
BASIC QUALIFICATIONS | EDUCATION:
  • Bachelor Degree in Pharmacy/Science/Engineering.
  • Must have been employed in the Medical Device/Pharmaceutical /In-Vitro Diagnostics/Healthcare industry for a minimum of 7 years.
  • Minimum of 10 years of experience in Quality Assurance and /or Compliance in a regulated industry.
  • Minimum of 3 years supervisory / managerial experience
  • Ability to effectively communicate in English.
COMPETENCIES:
  • Strong leadership influence.
  • Strong analytical, communication, decision-making 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 leadership skills, including the ability to set goals and provide constructive feedback respectfully in order to build positive relationships and improve business results.
  • Capable of understanding and overcoming different cultural and language barriers to provide solutions that satisfy corporate, regional, and local objectives.
  • 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 in a highly matrixed and geographically diverse business environment.
  • Ability to work effectively within a team in a fast-paced changing environment. Multi-tasks, prioritizes and meets deadlines in timely manner.
  • Experience in conducting and handling audits and inspections.

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