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.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com