Job Description

Abbott is a global healthcare leader, creating breakthrough science to improve people\xe2\x80\x99s health. We\xe2\x80\x99re always looking towards the future, anticipating changes in medical science and technology. RESPONSIBILITIES:

• As part of the IDEM quality team, responsible for establishing, maintaining, and improving quality and compliance in the APAC commercial structure. This includes being a strategic partner to APAC commercial leadership, communicating the importance of an effective and compliant Quality System to Abbott employees and partners, assessing and reporting on Quality System effectiveness to Abbott management, and promoting a Quality First culture. Overall serve as voice of quality on Regional Commercial leadership team.
• Develop the Quality strategy in alignment with regional commercial strategy and the global quality strategy.
• Responsible for leading and managing quality and compliance matters associated with APAC affiliates and their distributors as well as the implementation, maintenance, and improvement of Quality Systems and processes that are appropriate for the functions performed, and that comply with applicable regulations and Abbott IDEM and global policies and standards.
• Embed quality management system into the business processes and ensure compliance to local Health Authority requirements, and Abbott Quality Standards.
• Oversee APAC affiliates in the development and implementation of quality improvement plans, as necessary, that take a risk-based approach in addressing identified deficiencies, corrections and improvements.
• Responsible for the management and development of APAC Commercial\xe2\x80\x99s key quality personnel, including organizational structure, workload analysis, recruitment, competency assessment, appointment and dismissal, and management of regional quality budget.
• Ensure implementation of applicable regulatory requirements into operating processes and work instructions and ensure effective cascade in the commercial organization.
• Provide quality input and strategic direction to the APAC Commercial organization in order to influence compliant and business efficient decisions relating to organizational structure, operating locations, product improvement, quality management systems/processes, mergers and acquisitions, post market activities and business relationships.
• Ensure engagement of commercial and cross-functional partners through the Management Review to ensure appropriate resources and support are provided to execute quality systems effectively.
• Collaborate with APAC Regulatory leadership to assess impact of new regulatory requirements on Abbott entities and distributors, and ensure timely implementation of aligned, efficient and least burdensome processes that meet the requirements of the regulation.
• Conduct existing and new business assessments and identify strategic improvement and deployment projects.
• Develop effective process performance metrics and targets.
• Manage the overall corrective action and preventive action (CAPA) and risk management processes.
• Utilize Abbott and industry quality metrics to identify risks for the organization in order to direct and support development/implementation of APAC Commercial policy, procedure, training, and other available tools for reducing identified risks.
• Responsible for ensuring all APAC Commercial affiliates are \xe2\x80\x9caudit ready\xe2\x80\x9d by implementing, appropriate programs to ensure entity compliance with applicable regulations, Abbott policies and standards and for providing guidance, support and resources to address identified deficiencies.
• Act as a key business partner for quality and process improvement, understand business requirements, and execute quality and continuous improvement programs to drive organization capability building.
• Participates in activities with national competent authorities and APAC regional quality organizations and other external stakeholders with a view to enhancing the profile and the perception of Abbott as an ethical, responsible and compliant corporation.

QUALIFICATIONS & EXPERIENCE :

• Minimum bachelor\xe2\x80\x99s degree in science, engineering or health-related discipline with 10 years\xe2\x80\x99 industry or related experience and a minimum of 7 years\xe2\x80\x99 experience in a medical device/Pharmaceutical or IVD quality environment.
• Demonstrated ability to influence change upwardly and laterally across the business.
• Ability to merge business and compliance needs to achieve effective solutions.
• Extensive experience in Quality System implementation, management and monitoring, and demonstrated track record in execution of effective quality system inspections/audits (ISO mandatory, US FDA desirable) is required.
• Must be skilled in interpreting competent authority and notified body regulations and guidelines; including converting these into practical direction to non-quality/regulatory colleagues.
• Strong leadership capabilities and a proven track record of leading or coaching teams to achieve significant quality and process improvements.
• Experience of managing multiple countries/markets with diverse environment.
• Demonstrated experience of people development.
• Experience in conducting and handling audits and inspections.

COMPETENCIES:

• Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners.
• Strong ability to negotiate with stakeholders.
• Capable of managing complexity across the business to consistently deliver customer expectations while meeting internal and external compliance requirements.
• 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.
• 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.
• Multitasks, prioritizes and meets deadlines in timely manner.

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.